Summary of Position
Reporting to the Facilities Manager, this position will have direct responsibility for preventive maintenance, repairs and improvements of all support equipment around the facility. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the highest level of cleanliness and safety possible in support of our mission to foster a desirable work environment for all employees and guests to our facility. Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
Essential Functions
- In the absence of a supervisor, help coordinate daily production schedules within area and drive solutions for other issues that directly impact production
- Perform and document routine preventive maintenance activities in various areas of the facility. Ex. Compressor room, HVAC systems, forklift, hoists, etc.
- Lead projects throughout the facility focused on cosmetic enhancement, functional improvement, or to support safety initiatives.
- Direct and support full machine cleanouts to remove chips and change coolant and basic machine repair.
- Operation of the Chip Spinner to reclaim coolant and separate from metal chips.
- Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
- Weekly/monthly inspections
- Timely completion of facilities requests.
- Additional duties/responsibilities will be required, but not noted, per the Plant’s needs.
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
Experience
- Minimum of 3-5 years’ experience in facilities maintenance.
Qualifications
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
- Ability to use basic hand-held tools to support maintenance activities.
- Demonstrated coaching or training skills to drive departmental and company objectives.
- Forklift and OSHA training required.
- Ensure completion of managerial duties in the absence of manager.
- Help to schedule/work with outside contractors
- Ensure completion of facilities requests
- Help to delegate tasks given by manager and follow up for completion.
Physical Demands
- Occasionally lift and/or move up to 50 pounds.
- Frequently sit and/or stand.
- Use of hands to fingers well being able to handle and/or touch objects tools or controls.
Summary of Position Reporting to the Facilities Manager, this position will have direct responsibility for preventive maintenance, repairs and improvements of all support equipment around the facility...
Summary of Position
Reporting to the Supply Chain Manager, this position is responsible for supporting operations with product flow as needed. TOMZ corporation, a company specializing in high-precision metal machining, finishing, assembly, and anodizing for Medical Devices. The successful candidate will maintain the highest level of traceability in handling the receipt, storage, and issuance of raw materials, ensuring smooth support for manufacturing processes while adhering to regulatory and quality standards.
Essential Functions
- Receipt and incoming inspection of all raw materials.
- Appropriate storage of all raw materials including ERP transactions and physical locations.
- Issue raw materials to manufacturing operations.
- Perform and document routine cycle counts to ensure proper inventory levels are maintained.
- Print Job Travelers as required to support production flow.
- Perform the “SAW” operation for all required materials prior to issuing to production floor.
- Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
- Monitor and order office and shop supplies.
- Order production tooling and enter into inventory when received.
- Support manufacturing as needed.
- Adhere to the TOMZ Quality Management System.
- Perform other duties as assigned.
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
Experience
- Minimum of 2-5 years’ experience in a regulated manufacturing environment.
Qualifications
- "Hands-on” self-starter with ability to work both independently and as part of a team.
- Demonstrated ability to manage inventory levels.
- Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
- Ability to use basic hand-held tools and inspection equipment to support receiving inspection activities.
- Forklift training required.
Physical Demands
- Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
- Perform keyboard entries with possible frequent operation of a computer.
- Ability to use power tools as needed.
- As needed to comply with safety requirements - need to wear safety equipment such as cut resistant gloves, safety glasses, hearing protection, steel toe and slip resistant shoes.
Summary of Position Reporting to the Supply Chain Manager, this position is responsible for supporting operations with product flow as needed. TOMZ corporation, a company specializing in high-precisio...
Summary of Position
Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within the Swiss machining department. TOMZ manufactures parts via high- precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machined components using various precision measuring equipment.
Essential Functions
- Set up and operate and maintain Citizen Lathes or Tsugami Lathes.
- Perform offsets and tool changes to ensure efficient production with minimal support.
- Set up complex legacy components and new production orders for steady machine operation.
- Perform preventative maintenance on Swiss Lathe to ensure consistent machine performance
- Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.
- Perform scheduled and regular preventive maintenance on equipment.
- Drive problem-solving activities for complex machine or process issues.
- Complete and compile documentation related to quality inspection standards.
- Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
- Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
- Capable of mentoring and training lower-level machinists.
- Facilitate a continuous improvement in culture and ensure quality and delivery objectives are met.
- Utilize ERP and QMS systems to document and control inspection and traceability activities.
- Maintain safe working conditions and follow occupational safety and health requirements, including PPE guidance.
- Adhere to the TOMZ Quality Management System.
- Perform other duties as assigned.
Qualifications:
Education
- Certification from a technical school program or equivalent, directly transferable work experience in a manufacturing or engineering discipline may be accepted.
- Certification from a technical school program is strongly preferred.
Experience
- Minimum of 3-7 years’ experience in a regulated manufacturing environment.
Qualifications
- Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
- Strong math background, preferable in machine math/shop math
- Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
- Knowledge of and experience with GMP/ISO standards.
- A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results with minimal guidance.
- Advanced understanding of mechanical equipment usage, care, and inspection processes.
- Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
- Skilled in reading and understanding of blueprints, specifications, and procedures.
- Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
- Proficient in identifying nonconformances and maintaining organization.
- Intermediate skills in GD&T.
Preferred Skills
- Strong verbal and written English language communication skills.
Physical Demands
- Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
- Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
- 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
- Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
- Ability to sit or stand for prolonged periods.
Summary of Position Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within the Swiss machining department. TOMZ manuf...
Summary of Position
Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within a machining Department. TOMZ manufactures parts via high- precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machined components using various precision measuring equipment.
Essential Functions
- Set up and operate and maintain Citizen Lathes or Tsugami Lathes
- Perform offsets and tool changes to ensure efficient production with minimal support.
- Set up legacy components and new production orders for steady machine operation.
- Perform preventative maintenance on Swiss Lathe to ensure consistent machine performance
- Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.
- Perform scheduled and regular preventive maintenance on equipment.
- Drive problem-solving activities for complex machine or process issues.
- Complete and compile documentation related to quality inspection standards.
- Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
- Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
- Utilize ERP and QMS systems to document and control inspection and traceability activities.
- Maintain safe working conditions and follow occupational safety and health requirements, including PPE guidance.
- Adhere to the TOMZ Quality Management System.
- Perform other duties as assigned.
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
- Certification from a technical school program preferred.
Experience
- Minimum of 2-5 years’ experience in a regulated manufacturing environment.
Qualifications
- Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
- Strong math background, preferable in machine math/shop math
- Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
- Knowledge of and experience with GMP/ISO standards.
- A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results with guidance.
- Understanding of mechanical equipment usage, care, and inspection processes.
- Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
- Effectively read and understand blueprints, specifications and procedures.
- Understanding of GD&T.
- Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
- Identify nonconformances and maintain organization.
Preferred Skills
- Strong verbal and written English language communication skills.
Physical Demands
- Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
- Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
- 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
- Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
- Ability to sit or stand for prolonged periods
Summary of Position Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within a machining Department. TOMZ manufactures ...
Summary of Position
Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within the Swiss machining department. TOMZ manufactures parts via high- precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machined components using various precision measuring equipment.
Essential Functions
- Set up and operate and maintain INDEX multi-spindle lathes.
- Perform offsets and tool changes to ensure efficient production with minimal support.
- Set up complex legacy components and new production orders for steady machine operation.
- Perform preventative maintenance on INDEX to ensure consistent machine performance
- Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.
- Perform scheduled and regular preventive maintenance on equipment.
- Drive problem-solving activities for complex machine or process issues.
- Complete and compile documentation related to quality inspection standards.
- Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
- Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
- Capable of mentoring and training lower-level machinists.
- Facilitate a continuous improvement in culture and ensure quality and delivery objectives are met.
- Utilize ERP and QMS systems to document and control inspection and traceability activities.
- Maintain safe working conditions and follow occupational safety and health requirements, including PPE guidance.
- Adhere to the TOMZ Quality Management System.
- Perform other duties as assigned.
Qualifications:
Education
- Certification from a technical school program or equivalent, directly transferable work experience in a manufacturing or engineering discipline may be accepted.
- Certification from a technical school program is strongly preferred.
Experience
- Minimum of 3-7 years’ experience in a regulated manufacturing environment.
Qualifications
- Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
- Strong math background, preferable in machine math/shop math
- Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
- Knowledge of and experience with GMP/ISO standards.
- A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results with minimal guidance.
- Advanced understanding of mechanical equipment usage, care, and inspection processes.
- Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
- Skilled in reading and understanding of blueprints, specifications, and procedures.
- Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
- Proficient in identifying nonconformances and maintaining organization.
- Intermediate skills in GD&T.
Preferred Skills
- Strong verbal and written English language communication skills.
Physical Demands
- Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
- Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
- 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
- Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
- Ability to sit or stand for prolonged periods.
Summary of Position Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within the Swiss machining department. TOMZ manuf...
Summary of Position
Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within a machining Department. TOMZ manufactures parts via high- precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machined components using various precision measuring equipment.
Essential Functions
- Set up, operate and maintain INDEX multi-spindle lathes.
- Perform offsets and tool changes to ensure efficient production with minimal support.
- Set up legacy components and new production orders for steady machine operation.
- Perform preventative maintenance on INDEX machine to ensure consistent machine performance
- Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.
- Perform scheduled and regular preventive maintenance on equipment.
- Drive problem-solving activities for complex machine or process issues.
- Complete and compile documentation related to quality inspection standards.
- Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
- Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
- Utilize ERP and QMS systems to document and control inspection and traceability activities.
- Maintain safe working conditions and follow occupational safety and health requirements, including PPE guidance.
- Adhere to the TOMZ Quality Management System.
- Perform other duties as assigned.
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
- Certification from a technical school program preferred.
Experience
- Minimum of 2-5 years’ experience in a regulated manufacturing environment.
Qualifications
- Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
- Strong math background, preferable in machine math/shop math
- Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
- Knowledge of and experience with GMP/ISO standards.
- A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results with guidance.
- Understanding of mechanical equipment usage, care, and inspection processes.
- Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
- Effectively read and understand blueprints, specifications and procedures.
- Understanding of GD&T.
- Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
- Identify nonconformances and maintain organization.
Preferred Skills
- Strong verbal and written English language communication skills.
Physical Demands
- Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
- Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
- 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
- Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
- Ability to sit or stand for prolonged periods
Summary of Position Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within a machining Department. TOMZ manufactures ...
TOMZ Corporation is in search of a Quality Inspector to join our team! A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Some of those include 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.
Summary of Position
Reporting to the Department Manager, this position will have direct responsibility for the quality control functions within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation and/or perform inspections on machined components · Perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques. Faced paced work environment.
Essential Functions
- Perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques.
- Perform and provide training assistance for inspections on machined components, as required, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers and gages.
- Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
- Completes and compiles necessary documentation related to Quality Inspection standards.
- Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
- Accurately review and ensure Good Document Practices (GDP) are upheld for Routers/Inspection Plans/Device History Records (DHRs) throughout the manufacturing process and in preparation for final lot release/shipment.
- Support Quality Best Practices and GDP/GMP continuous improvement efforts.
- Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
- Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.
- Generate Packing Slips and Certificates of Compliance (C of C) in accordance with TOMZ and/or customer requirements.
- Support physical and/or electronic record retention.
- Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
- Adhere to the TOMZ Quality Management System.
- Perform other duties as assigned.
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
Experience
- Minimum of 3-5 years’ experience in a regulated manufacturing environment.
Qualifications
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
- Ability to effectively read and understand blueprints, specifications, and procedures.
- Knowledge of dimensional, visual and mechanical inspection processes.
- Strong background concerning the usage and care of mechanical measurement equipment, tools and hand-held tools including micrometers, calipers, dial indicators, height gages, pin gages, etc.
- Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Strong verbal and written English language communication skills.
- Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.
Preferred Skills
- Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
- Class I, II and/or III Medical Device manufacturing experience.
- Knowledge of and experience with GMP/ISO standards.
TOMZ Corporation is in search of a Quality Inspector to join our team! A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and ...
TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Machinist III to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.
Summary of Position
Reporting to Department Manager, this position will have direct responsibility for the setup and manufacture of components within a machining Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, setup and operate equipment, and perform visual and dimensional inspections on machined components.
Essential Functions
- Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills.
- Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
- Ability to efficiently setup complex legacy components and basic new production orders and ensure the machine is ready for steady production.
- Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, CMM, Vision system, etc.
- Regularly and as prescribed, perform preventive maintenance of equipment.
- Drive problem solving activities for complex machine or process issues.
- Completes and compiles necessary documentation related to Quality Inspection standards.
- Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
- Support Quality Best Practices and GDP/GMP continuous improvement efforts.
- Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
- Must maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Other duties and responsibilities are assigned
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
- Certification from a technical school program strongly preferred.
Experience
- Minimum of 3-7 years’ experience in a regulated manufacturing environment.
Qualifications
- Class I, II and/or III Medical Device manufacturing experience.
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
- Knowledge of and experience with GMP/ISO standards.
- Advanced understanding of the usage and care of mechanical equipment and inspection processes.
- Ability to use hand-held tools to perform preventive maintenance or repair activities and install or change tools.
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Ability to effectively read and understand blueprints, specifications, and procedures.
- Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.
Preferred Skills
- Strong verbal and written English language communication skills.
Physical Requirements
- Occasionally lift/move up to 50 pounds this may be performed with assistants if needed.
- Prolonged periods of sitting.
Job Features
TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Machinist III to join our organization. TOMZ offers competitive compensation ...
TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Engineering Technician to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.
Summary of Position
This position will be responsible for the activities associated with Inspection/Test Method development and improvement. This role will be expected to collaborate with Quality Engineering to support sustaining manufacturing and product development.
Essential Functions
- Programming automated metrology systems such as CMM’s and Vision Systems.
- Author Quality Inspection documentation such as Inspection Plans, with appropriate inspection methods and frequency rationales.
- Support the creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
- Support the generation and maintenance of Process Control Plans.
- Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
- Contribute to test method development and selection.
- Knowledge of precision measuring instruments and their application, including but not limited to, calipers, micrometers, depth gages, indicators, and plug and thread Go/No Go gages.
- Assist in the execution and/or data collection of Test Method Validations and Gage R&R’s.
- Review standard inspection labor times for first article, first piece inspection, in-process and final inspection.
- Collaborate with Quality Engineering to identify and implement inspection cycle time reduction continuous improvement opportunities.
- Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
- Support the generation of “redlines” for updates to Quality Engineering and Inspection documentation.
- Generate ECOs for the release of Quality Engineering documentation.
- Other duties and responsibilities as assigned.
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
Experience
- Minimum of 2-5 years’ experience in a regulated manufacturing environment.
Qualifications
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
- Knowledge of and experience with GMP/ISO standards.
- Knowledge of and the ability to read geometric dimensions and tolerances.
- Previous experience programming CMM’s and/or vision systems.
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA as required accomplishing results with minimal guidance.
- CMM operation, setup, and programing highly preferred.
Preferred Skills
- Strong verbal and written English language communication skills.
- Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint
Physical Demands
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Engineering Technician to join our organization. TOMZ offers competit...
TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Quality Engineer to join our organization! Founded in 1988, TOMZ continues to be a family owned and operated organization which offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.
Summary of Position
This position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.
Essential Functions
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Author and execute Quality Plans for Quality Product Design and Development projects.
- Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
- Establish severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
- Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
- Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectiveness.
- Provide direction in implementing Incoming, In-Process, and Final Product Inspection plans.
- Develop and justify appropriate sampling plans with characterization of test/inspection methods.
- Champion First Article Inspections and Component Qualifications.
- Represent Quality Engineering in design reviews throughout the process development process.
- Support initial qualification audit activities (Customer and Regulatory Agencies).
- Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
- Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Ensure compliance of all site personnel to site-level QMS and training requirements.
- May support the development of Quality Agreements for external customers.
- Other duties and responsibilities as assigned.
Qualifications:
Education
- Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
Experience
- Minimum of 4+ years of experience in a regulated manufacturing environment.
Preferred Skills/Qualifications
- Advanced Post-Secondary Education/Training/Certification coursework
- Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
- Class I, II, and/or III Medical Device manufacturing experience.
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.).
- Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
- Experience in effectively supporting audits by customers and external regulatory agencies.
- Strong verbal and written English language communication skills.
- Successfully meet TOMZ-specific positional/functional on-the-job training requirements.
- Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.
Physical Demands
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Quality Engineer to join our organization! Founded in 1988, ...
Our Mission
To enhance the lives of patients by sustainably manufacturing innovative medical devices for leading OEMs around the globe.


We Manufacture Medical Devices
We specialize in manufacturing the best medical device implants for medical teams and surgeons around the world. Most of our team will tell you that the work is very fulfilling because we help people live better lives.
Company Values & Culture
Our DNA is as unique as everyone that works here.

Put Patients First

Embrace Diversity

Learn & Grow

Reward Great Effort
Why Work at TOMZ?
We are large enough to offer stability and great benefits, yet small enough to recognize you as an individual and not just “another employee.”
Multiple departments from facilities management to engineering allows you to explore different career paths.
The medical devices industry is experiencing explosive growth with no signs of stopping any time soon.
We have completed our 8th expansion which includes amenities such as locker rooms, showers, an expanded cafeteria, and more.
We have a deep bench of knowledgeable pros to help you.
Everything from 401K to top-of-the-line healthcare, life insurance, and more!
What Our Team Members Have to Say
Playlist
Benefits
401(k) Retirement Plan
We will match $0.50 on the dollar up to an 8% contribution. Work with us, retire with us.
Overtime Available
Opportunities to earn overtime hours are available as needed.
Paid Holidays
Enjoy 9 paid holidays off per year.
Paid Time Off (PTO)
PTO starts accruing from the day you start.
Referral Bonus
Employees are eligible to earn a $3,500 referral bonus!
Health Insurance Plans
Enjoy a low employee co-pay with high contributions towards your plan.
Dental Insurance Plans
Yes - we have a great dental plan as well!
Quarterly Bonus
Teams achieving set performance goals receive a quarterly performance bonus.