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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Staff Quality Engineer 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 certified to ISO 13485.

Summary of Position

This position will be responsible for the activities associated with Quality Engineering, Control and Assurance continuation development support for continuous improvement of manufacturing processes.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Author and execute Manufacturing Quality Plans, Control Plans and Master Validation Plans.
• Leads on strategic initiatives to improve Quality Processes and Systems.
• Owns the development and/or update of Risk Management files in cooperation with cross-functional engineering teams, operations and customers.
• Supports the procurement and qualification of capital equipment.
• Operates and programs advanced measurement equipment including Vision Systems and CMMs.
• Authors Inspection Plans and defines process controls. Defines Test Method.
• Subject Matter expertise 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.
• Execution and evaluation of Test Method Validations.
• Creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
• Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
• Performs process qualifications, analyzes data and initiates corrections or corrective actions as required
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, resolving quality issues through the CAPA process.
• Defines and Measures KPI’s for New Product Introduction.
• Interfaces with the customer and meets all defined deliverables.
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
• Generate ECOs for the release of Quality Engineering documentation.
• Other duties and responsibilities as assigned.

Qualifications:

Education/Experience

• Bachelor's or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.
• Minimum of 0-4 years’ experience in a regulated manufacturing environment.
• Engineering degree and 7+ years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming. (12+ years of experience in Quality Engineering or similar discipline will be considered in lieu of a degree)

Qualifications

• Ability to travel up to 20%.
• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office (Visio, Project, Outlook, Word, Excel, and PowerPoint)
• Strong verbal and technical writing capabilities (English language).
• Expertise is statistical techniques, GD&T, process validation, and Metrology.
• Demonstrated ability to work in and lead teams through large scale projects.

Preferred Skills

• ASQ CQE or CRE.
• Expertise in 3D modeling Solid Works, Unigraphics, Mastercam, Solid Edge, etc.
• Six Sigma Green or Black belt.
• Certifications in DMIS programming preferred
• Regulated manufacturing industry experience preferably Class I, II and/or III Medical Device manufacturing experience. (exp: Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge and experience with external standards: ISO 9000/9001, 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).

Summary of Position

Reporting to the Department Manager, this position will have direct responsibility for the processing of parts through various functions within the 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, prepare materials to be processed through various operations, and perform basic visual and dimensional inspections on completed components.

Essential Functions

• Prepare and process components through various metal finishing operations.
  • Tumbling
  • Blasting
  • Heat Treat
  • Laser Welding
  • Laser Marking
  • Passivation
  • Anodize
• Perform visual and basic dimensional inspections on completed components, as required using micrometers, calipers, microscope, etc.
• 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 follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities are assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 0-2 years’ experience in a regulated manufacturing environment.

Qualifications

• Ability to use basic hand-held tools to support preventive maintenance activities.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Strong verbal and written English language communication skills.
• Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
• Must have good organizational skills.

Preferred Skills

• Ability to effectively read and understand blueprints, specifications, and procedures.
• Knowledge of and experience with GMP/ISO standards.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Class I, II and/or III Medical Device manufacturing experience

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 frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds while moving components or fixtures/racking. 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.

$19 - $22 an hour

Summary of Position

Reporting to Quality leadership, 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 perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

Essential Functions

• Demonstrate team leadership, train, and provide guidance to Quality Control personnel.
• Aligns and prioritizes workload. Creates targets and expectations for work performance.
• Coaches and corrects team as required.
• Provides input for performance appraisals to employees.
• Train and perform inspections on machined components and assemblies using visual and layout techniques and equipment, such as microscopes, calipers, micrometers, and gages.
• Create, complete, and compile documentation related to Quality Inspection standards, ensuring proper material control, identification, and traceability throughout the manufacturing processes.
• Ensure conformance to Quality standards by reviewing Device History Records (DHRs) and ensuring they align with the Device Master Record (DMR), and that Good Document Practices (GDP) are maintained for Routers, Inspection Plans, and DHRs during the manufacturing process and final lot release.
• Utilize ERP and QMS systems to document inspection activities, ensure traceability, and maintain proper control of records.
• Support continuous improvement efforts aligned with Quality Best Practices and GDP/GMP standards.
• Execute Incoming, In-process, and Final Inspections as assigned, recording nonconformities, ensuring follow-up actions, and moving materials into MRB if issues remain unaddressed.
• Perform material sorts as needed, ensuring nonconformities are identified and addressed.
• Follow safety and health requirements, including Personal Protective Equipment (PPE) guidance and rules, throughout all tasks.
• Adapt to different quality standards, production lines, and teams, and move between multiple departments and production lines as required with a proactive approach.
• Support other Quality Department functions as needed, ensuring flexibility in role responsibilities.
• Support physical and electronic record retention processes as needed.
• Ability to use more complex measurement equipment (Comparator, Vision System, Basic CMM operation)
• Performs process audits to ensure that processes are being performed in accordance with procedures and standard work.
• Trains others to clarify standards and requirements.
• Train and perform further complex inspections on machined components utilizing methods such as comparators, CMM, vision systems, contracers and automated techniques.
• Provide basic programming assistance for complex inspection and test methods, as required.
• Execute First Piece, FAI Inspection, as assigned.
• Supervises and trains others on sorting activities and inspections.
• Evaluates compliance process controls (i.e. SPC, Precontrol, Tool Life, Process Parameter) and train others on process standards.
• 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 5 years’ experience in a regulated manufacturing environment or equivalent education and experience.

Qualifications

• The 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.
• Knowledge of dimensional, visual, and mechanical inspection processes.
• Competency with Microsoft Office.
• Ability to work both independently and as part of a team.
• Verbal and written English language communication skills.
• Basic mathematical computational ability
• 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.
• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g., Aerospace, Defense, Pharmaceutical, etc.)

Preferred Skills

• Quality certification(s) (e.g., ASQ CQT, QCI, etc.).
• Knowledge of and experience with GMP/ISO standards.

$27- $32 an hour

TOMZ is an Equal Opportunity Employer

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior Maintenance Machine Specialist 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

The purpose of the Senior Maintenance Machine Specialist is to provide production equipment support for all equipment allocated to the Factory as well as to assist engineering with production-related projects. Routinely works with Plant Maintenance to coordinate jobs and projects. The Senior Maintenance Machine Specialist will take the lead in the implementation and the decision-making process on best practices for the maintenance group. The position is also responsible for creating solutions and providing technical support to enhance production reliability through concerted efforts with cross functional teams.

Essential Functions

Duties and responsibilities include, but are not limited to:

• Adherence to all department safety measures and work instructions.
• Accountable for personal safety, the safety of co-workers and promoting a safe work environment.
• Repair and maintain all production equipment, both electrical and mechanical.
• Assist engineering as required with special machine related projects.
• Work with CONC and PLC controlled machines.
• Routinely work in electrical control panels of production equipment to troubleshoot electrical problems.
• Arc Flash certified worker to work “live” electrical control panels.
• Working understanding of precision measuring instruments used in troubleshooting.
• Read and interpret diagrams, schematics and specifications related to equipment operation.
• Monitor, modify, or write programmable ladder logic circuits as needed for existing or new installations.
• Create electrical drawings, PLC programs to be used for troubleshooting of modified equipment.
• Install electrical, air and data drops to equipment and machines.
• Work with outside contractors for equipment repair of production machines as needed and verify completion accuracy.
• Design and implement electrical circuits and technologies for support of production equipment.
• Initiate or enhance the preventative maintenance schedules for production equipment.
• Calibrate equipment using general and special purpose test equipment.
• Facilitate equipment modifications, upgrades, overhauls, and root cause failure analyses.
• Ensure respective area is complaint with 5S Standards.
• Maintain daily log of work in established systems.
• Support ISO 13485 initiatives.
• Assist in training individuals with less experience and tenure on established maintenance standards and practices.
• Project initiation and improvement ideas to better production and the business.
• Purchase repair parts, tools, and supplies in appropriate ERP software.
• Provide input for annual department budget planning.
• Ability to work flexible hours (including overtime) to accommodate production working hours as needed.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Associate degree in a technical related field or equivalent experience

Experience

• Minimum 10 years’ experience in the Equipment Maintenance Field

Qualifications

• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Maintains accuracy, is detail oriented, and completes tasks in a timely manner.
• Prior experience with CNC and PLC controlled equipment.
• Experience with MS Office Programs.
• Ability to perform routine maintenance of CNC manufacturing equipment; troubleshoot issues and support, or directly resolve as appropriate.
• Ability to read and interpret documents and drawings (e.g., blueprints, manuals, wiring diagrams etc.)
• Time management skills and ability to prioritize workflow throughout the day.
• Strong verbal and written English language communication skills.

Preferred Skills

• Forklift and OSHA Training.

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 frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds while moving tooling, fixtures, equipment and/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.

Pay Range: $29.81/hr - $43.75/hr

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior Maintenance Machine Specialist 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

The purpose of the Senior Maintenance Machine Specialist is to provide production equipment support for all equipment allocated to the Factory as well as to assist engineering with production-related projects. Routinely works with Plant Maintenance to coordinate jobs and projects. The Senior Maintenance Machine Specialist will take the lead in the implementation and the decision-making process on best practices for the maintenance group. The position is also responsible for creating solutions and providing technical support to enhance production reliability through concerted efforts with cross functional teams.

Essential Functions

Duties and responsibilities include, but are not limited to:

• Adherence to all department safety measures and work instructions.
• Accountable for personal safety, the safety of co-workers and promoting a safe work environment.
• Repair and maintain all production equipment, both electrical and mechanical.
• Assist engineering as required with special machine related projects.
• Work with CONC and PLC controlled machines.
• Routinely work in electrical control panels of production equipment to troubleshoot electrical problems.
• Arc Flash certified worker to work “live” electrical control panels.
• Working understanding of precision measuring instruments used in troubleshooting.
• Read and interpret diagrams, schematics and specifications related to equipment operation.
• Monitor, modify, or write programmable ladder logic circuits as needed for existing or new installations.
• Create electrical drawings, PLC programs to be used for troubleshooting of modified equipment.
• Install electrical, air and data drops to equipment and machines.
• Work with outside contractors for equipment repair of production machines as needed and verify completion accuracy.
• Design and implement electrical circuits and technologies for support of production equipment.
• Initiate or enhance the preventative maintenance schedules for production equipment.
• Calibrate equipment using general and special purpose test equipment.
• Facilitate equipment modifications, upgrades, overhauls, and root cause failure analyses.
• Ensure respective area is complaint with 5S Standards.
• Maintain daily log of work in established systems.
• Support ISO 13485 initiatives.
• Assist in training individuals with less experience and tenure on established maintenance standards and practices.
• Project initiation and improvement ideas to better production and the business.
• Purchase repair parts, tools, and supplies in appropriate ERP software.
• Provide input for annual department budget planning.
• Ability to work flexible hours (including overtime) to accommodate production working hours as needed.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Associate degree in a technical related field or equivalent experience

Experience

• Minimum 10 years’ experience in the Equipment Maintenance Field

Qualifications

• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Maintains accuracy, is detail oriented, and completes tasks in a timely manner.
• Prior experience with CNC and PLC controlled equipment.
• Experience with MS Office Programs.
• Ability to perform routine maintenance of CNC manufacturing equipment; troubleshoot issues and support, or directly resolve as appropriate.
• Ability to read and interpret documents and drawings (e.g., blueprints, manuals, wiring diagrams etc.)
• Time management skills and ability to prioritize workflow throughout the day.
• Strong verbal and written English language communication skills.

Preferred Skills

• Forklift and OSHA Training.

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 frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds while moving tooling, fixtures, equipment and/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.

Summary of Position

Supervises production team in assigned department(s). Improve safety, quality, delivery, productivity, and cost. Increase team skills and capabilities. Continuously improves associate satisfaction while increasing efficiency.

Essential Functions

• Safe operation of all production processes. Identifies needed improvements and leads the project's implementation. Continually monitors the area and solicits feedback from associates. Enforce all safety rules and regulations.
• Is the key coordinator/communicator for at least one safety training program for the entire organization.
• Supervises team members. Ensures effective employee relations. Resolves issues through problem resolution. Confers with management to resolve complex associate matters.
• Interviews, selects, orients, trains, conducts performance appraisals, performance development, schedules, and approves hours.
• Provides leadership for associate relations through effective communication, coaching, training, and development.
• Executes operational plan to enhance profitability, productivity, and efficiency throughout assigned production department(s).
• Implements Lean Manufacturing techniques to improve quality, cost, on-time delivery, safety, customer satisfaction, and associate satisfaction.
• Maintains production plan.
• Ensures compliance with the organization's standards for cost control, waste reduction, quality, safety, and on-time delivery.
• Provides training and support to the team, sets goals and objectives.
• Measures team performance for safety, quality, delivery, and cost. Work with teams to continually improve these measures.
• Monitors the budget.
• Arranges for equipment, materials, and supplies to be available for work assignments.
• Approves setups and assigns operators. Troubleshoot bottleneck operations to identify the cause and notify the appropriate support team for assistance.
• Checks work methods and operations to make recommendations for improving quality and implement systems to report and reduce scrap and cost.
• Oversees the use of SPC.
• Identifies opportunities aimed at continuous improvement of the quality of products and processes. Leads project team during identification through implementation and evaluation.
• Confers with others to coordinate operations and activities across all shifts.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

Education

• Bachelor’s degree or 4-year equivalent directly transferable industry work experience.

Experience

• Minimum of 5 years of manufacturing or engineering experience in a supervisory role.

Qualifications

• Ability to maintain a safe work environment.
• Experience in the setup and operation of manufacturing equipment.
• Knowledge of production and processing and other techniques for maximizing the effective manufacture of our products.
• Broad experience with precision components and assembly.
• Kaizen and Lean Manufacturing techniques.
• High attention to detail and ability to think ahead.
• Knowledge of production cycle.
• Demonstrated ability to lead people and get results through others.
• Solid analytical skills
• Excellent interpersonal and communication skills to work with associates, customers and vendors.
• Excellent project and program management skills.
• Ability to multitask in a fast-paced environment and manage multiple priorities.
• Ability to solve practical problems and deal with a variety of changing situations.
• Quality orientation
• Knowledge of human resources and safety includes coaching, performance management, OSHA and related safety standards.
• Knowledge of mathematics to include geometry and statistics.
• Ability to think critically and use judgment to identify strengths and weaknesses of solutions to problems presented in production.
• Computer skills include word processing, spreadsheets, and databases.
• A self-starter capable of working independently and as part of a team

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.
• Ability to sit or stand for prolonged periods.
• Perform keyboard entries with frequent operation of a computer.
• Exposure to oil, grease, dust, metal particles, sparks, sharp-edged materials. Some exposures may require the use of personal protective equipment or engineering controls.

2nd shift- Start time 2PM