Join Us on Our Mission to Improve Patients' Lives.

Full Time
Berlin, CT
Posted 2 days ago

TOMZ Corporation is looking to hire a Sr. Quality Engineer – Sustained Manufacturing to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ 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 Sustained Manufacturing 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. Fast-paced work environment.

Essential Functions

  • Initiate and/or consult in the development and/or update of Risk Management FMEA documentation in cooperation with cross-functional engineering teams per project requirements.
  • Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams.
  • Provide direction in implementing and continuously improving Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
  • Ensure the continuous efficiency and improvement of Test/Inspection Methods
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPAs, Complaints and NCRs.
  • Other responsibilities required as outlined in full job description.

Qualifications:

Education

  • Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

  • Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

TOMZ Corporation is looking to hire a Sr. Quality Engineer – Sustained Manufacturing to join our organization. A leader in manufacturing of devices and components for major medical device companies,...

Full Time
Berlin, CT
Posted 2 days ago

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 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.
  • Other duties as required as outlined in full job description.

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.

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 ...

Full Time
Berlin, CT
Posted 2 days ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Inspector 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 successful candidate will be expected to perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

Technical Skills

  • Inspection Techniques: Proficiency in using various inspection methods like comparators, CMMs, microscopes, calipers, micrometers, and gauges.
  • Documentation: Ability to accurately complete and compile quality inspection documents according to established standards.
  • Material Control: Understanding of proper material identification and traceability throughout manufacturing processes.
  • Document Review: Familiarity with reviewing and ensuring Good Document Practices (GDP) for Routers, Inspection Plans, and Device History Records (DHRs).
  • Quality Systems: Experience using ERP and QMS systems for documenting and controlling inspection and traceability activities.
  • Packaging & Documentation: Knowledge of generating Packing Slips and Certificates of Compliance (C of C) according to requirements.
  • Records Management: Familiarity with physical and electronic record retention procedures.

Other Skills

  • Attention to Detail: Demonstrated ability to work meticulously and accurately.
  • Problem-Solving: Skill in identifying and resolving quality issues with machined components.
  • Communication: Effective communication skills to interact with colleagues, supervisors, and customers.
  • Safety: Commitment to following occupational safety and health requirements, including PPE use.

Additional Notes

  • The specific requirements of the role may vary depending on the company and industry.
  • Familiarity with the relevant regulations and standards for the industry is a plus.
  • Candidates with experience in the manufacturing environment will be at an advantage.

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, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Inspector to join our organization. TOMZ offers competitive compensat...

Full Time
Big Lake, MN
Posted 1 week ago

TOMZ Corporation is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ 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

Reporting to the Chief Commercial Officer, this position is primarily responsible for coordinating with cross-functional teams to successfully managing the development of new and existing Projects. Utilizing project management and system tools to track projects deliverables.

Essential Functions

  • Manage and coordinate activities related to the development, documentation, and validation of medical devices.
  • Generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities.
  • Coordinate activities across different functional groups within the company, customers, and suppliers to ensure successful completion of project goals and milestones.
  • Track project health in terms of schedule, budget, and technical risks utilizing project tracker.
  • Prepares and presents project status reports to internal and external stakeholders.
  • Proactively anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Additional responsibilities as outlined in the full job description.

Qualifications:

  • 4-Year degree or 5+ years manufacturing/equivalent of directly transferrable industry work experience
  • Experience in manufacturing in a regulated engineering/manufacturing environment.
  • Must be able to fully interpret technical drawings, specifications, process capability, and CNC manufacturing knowledge.

TOMZ Corporation is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation...

Full Time
Knightstown, IN
Posted 3 weeks ago

TOMZ Corporation is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ 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

Reporting to the Chief Commercial Officer, this position is primarily responsible for coordinating with cross-functional teams to successfully managing the development of new and existing Projects. Utilizing project management and system tools to track projects deliverables.

Essential Functions

  • Manage and coordinate activities related to the development, documentation, and validation of medical devices.
  • Generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities.
  • Coordinate activities across different functional groups within the company, customers, and suppliers to ensure successful completion of project goals and milestones.
  • Track project health in terms of schedule, budget, and technical risks utilizing project tracker.
  • Prepares and presents project status reports to internal and external stakeholders.
  • Proactively anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Additional responsibilities as outlined in the full job description.

Qualifications:

  • 4-Year degree or 5+ years manufacturing/equivalent of directly transferrable industry work experience
  • Experience in manufacturing in a regulated engineering/manufacturing environment.
  • Must be able to fully interpret technical drawings, specifications, process capability, and CNC manufacturing knowledge.

TOMZ Corporation is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation...

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
Surgical teams around the world rely on us to help improve their patient's lives. Our impact is on a global scale and our team members recognize the importance of their work.
Embrace Diversity
Our workforce is incredibly diverse by design. Individuals from different backgrounds offer valuable, unique perspectives. Diversity leads to innovation and open-mindedness.
Learn & Grow
We invest in our people, our facility, and technology to foster an environment of innovation and out-of-the-box thinking. Ideally, we all support the same mission.

Reward Great Effort

We consistently evaluate the work our team members do and reward them not only financially, but with growth opportunities as well. Your goal is our goal.

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

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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

9 paid holidays AND enjoy a half-day the work day before the paid holiday.

Paid Vacation

Paid vacation starts accruing from the day you start.

Referral Bonus

All 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!

Annual Bonus

Production teams achieving set performance goals receive an annual performance bonus.