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Summary of Position

The Assembly Test Technician is responsible for the set up and operation of various presses, fixtures, custom tooling, and measuring equipment used to produce complex finished assemblies from detail components. Understanding of blueprints, inspection reports, fixturing, and precise measuring will be required for daily tasks.

Essential Functions

• Setup and operation of presses, fixtures, and complex equipment.
• Comprehend and interpret drawings and comprehend work instructions.
• Complete inspection reports based off supplied blueprints.
• Proficiency with hand tools, basic assembly techniques, and measuring tools.
• Attention to detail while checking the function of the assembly per drawing requirements.
• Prior work experience in a regulated medical manufacturing environment or other highly regulated industrial manufacturing environment.
• Always maintains accuracy, attention to detail and completes tasks in a timely manner.
• Computer competency in a manufacturing environment.
• All other duties as assigned.

Qualifications:

Education

• High-school diploma or equivalent.

Experience

• 1-3 years’ experience in a manufacturing environment.

Qualifications

• Comprehension of blueprints
• Experience with hand operated tools
• Familiar with measuring equipment
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner
• Prior experience work experience in a regulated medical manufacturing environment or regulated medical manufacturing environment.

Join our team in Fishers, Indiana! 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

• 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.

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

Join our team in Berlin, CT!! Reporting to the Engineering Manager, the Manufacturing Engineer will have direct responsibility for developing and implementing robust cost-effective manufacturing processes and methods, recommends and improvements to sustained production processes, methods, and controls, as well as coordinate the launch of new products into volume production. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.

Essential Functions

• Support Production in reducing / eliminating equipment and tooling downtime or scrap.
• Perform tool life studies to drive efficiency and cost savings opportunities.
• Conduct Process Capability studies during manufacturing processes to support achieving objectives.
• Collaborates with cross-functional teams during the production transfer phase to establish and launch robust, mid to high volume processes.
• Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
• Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
• Develop and improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
• Additional responsibilities as outlined in the full job description.

Qualifications:

Education

• Minimum of a bachelor’s degree in an engineering discipline or equivalent experience.

Experience

• Minimum of 5 years’ experience within a regulated industry (preferably in a Medical Device or Aerospace contract Manufacturer).

Qualifications

• Must possess a high attention to detail.
• Ability to read drawings and specifications containing GD&T.
• Proficiency in SolidWorks.
• Proficient in the use of Microsoft Office and Adobe products.
• Solid knowledge of GMP and ISO 13485 regulations.
• Experience with continuous improvement activities, including participation and/or facilitating Kaizen events using lean manufacturing principles.
• Ability to work in a fast-paced Medical Device Manufacturing environment with high output efficiency and impeccable quality standards.

TOMZ Corporation is an Equal Opportunity Employer

We are hiring in Berlin, CT!! 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.

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

The purpose of the Senior Machine Maintenance Technician 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 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.

TOMZ Corporation is an Equal Opportunity Employer

Join our team in Berlin, CT!! Reporting to the Quality Engineering Manager this position will be responsible for the activities associated with Quality of commercial product and successful transfer of Development programs to standard production, through leadership, coaching and technical guidance of cross-functional Engineering teams. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches. Additionally, this role will serve as a critical team member for activities associated with Quality Control and Assurance during New Product Introduction activities.

Essential Functions

• Author and execute Manufacturing Quality Plans, Control Plans and Master Validation Plans to support New Product Introduction.
• Controls the development and updates of Risk Management files in cooperation with cross-functional engineering teams, operations, and customers.
• Authors Inspection Plans and defines process controls.
• 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.
• Review and disposition non-conformities utilizing MRB/NCR process.
• Performs process qualifications, analyzes data and initiates corrections or corrective actions as required
• Provides hands-on directions for executing Incoming, In-Process and Final Product Inspection plans.
• Support First Article Inspections.
• Support Gage calibration review, management, execution and evaluation.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Additional responsibilities as outlined in the full job description.

Qualifications:

Education

• Bachelor's or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.
• Engineering degree and 7+ years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming. (10+ years of experience in Quality Engineering or similar discipline will be considered in lieu of a degree

Experience

• Minimum of 7+ years’ experience in a regulated manufacturing environment.
• Prior experience as a Lead on a Program or with a customer. Prior experience mentoring a junior associate.

Qualifications

• Regulated manufacturing industry experience preferably Class I, II and/or III Medical Device manufacturing experience (exp: Aerospace, Defense, Pharmaceutical, etc.).
• Prior experience as a Lead on a Program or with a customer. Prior experience mentoring a junior associate.
• 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 are preferred.
• 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).

Travel Requirements

• Travel outside the workplace is possible for up to 10% of the year.
• Travel may include multiple overnight stays and may occasionally require weekend commitments

TOMZ Corporation is an Equal Opportunity Employer

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Housekeeper to join our organization. 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. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off.

Summary of Position

Reporting to the Facilities Manager, this position will have direct responsibility for the overall cleanliness of all common “High Contact” areas of the facility, and the front office. 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.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Daily routine cleaning of all common “High Contact” areas of the facility. Ex. include Cafeteria, hallways, door knobs and pulls, bathrooms and locker room area, and the front office.
• Routine vacuuming of carpeted areas and door mats.
• Occasional cleaning of windows, office dividers, and other glass per schedule and as needed.
• Light cleaning and trash removal of office areas.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience.

Experience

• Prior cleaning job experience.
• Must have reliable transportation.

Preferred Skills/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.
• Strong verbal communication skills.

Summary of Position

Reporting to 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 by utilizing conventional layout inspection techniques and equipment.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Train and perform inspections on machined components, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers, and gages.
• Train and perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques.
• Demonstrate team leadership, train, and provide guidance to Quality Control personnel.
• Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
• Creates, completes, and compiles necessary documentation related to Quality Inspection standards.
• Provide basic programming assistance for complex inspection/test methods, as required.
• 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.
• Support other Quality Department functions, as needed.
• 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 7 years’ experience in a regulated manufacturing environment.

Qualifications

• Quality certification(s) (e.g., ASQ CQT, QCI, etc.).
• 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.
• 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.
• 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.
• Strong verbal and written English language communication skills.
• 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, as required, accomplishing results with minimal guidance.