Skip to content

Join Us on Our Mission to Improve Patients' Lives.

tomzhiring | TOMZ Corporation
Full Time
Fishers, IN
Posted 14 hours ago

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).

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...

Full Time
Berlin, CT
Posted 15 hours ago

Join our team in CT! TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated CNC Programmer 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 the Applications Manager, this position will have direct responsibility for key production-related deliverables including but not limited to Manufacturing plan; Capacity planning; COGS estimation; Process validations; Capital equipment specifications and procurement; Production line set-up, as well as coordinate the launch of new products into production. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.

Essential Functions

  • This position may have direct-reporting responsibilities for daily activities of site Engineering personnel (responsibility dependent on geographic organizational structure).
  • Develop and perform installation, operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Ability to program various pieces of CNC equipment across multiple sites as directed to support critical and/or high-value projects milling, turning, and grinding, Multi spindle, Multi Axis and Swiss style programs for manufacture of medical devices- implants and instruments.
  • Analyze drawings, design models, and sketches to determine dimensions and configuration of cuts, selection of cutting tools, machine speeds, and feed rates according to shop processes, customer specifications, and machine capabilities
  • Actively participate in process development projects and DFM with internal and external teams
  • Revise programs to eliminate instruction errors, omissions, and update programs with new technology/methods to improve efficiency; meet customer delivery dates
  • Coordinate with Quality Engineering to help facilitate the development of Process Control Plans, Manufacturing Inspection Plans, and gaging/fixturing requirements.
  • Additional responsibilities as outlined in full job description.

Qualifications:

Education

  • Bachelor’s degree (mechanical engineering, biomedical engineering, or related) required, with a related advanced degree preferred.

Experience

  • Minimum of 7 years’ experience within a regulated industry (preferably in a Medical Device or Aerospace Manufacturer).

Preferred Skills/Qualifications

  • Project management experience – plan, development and execution.
  • Ability to read drawings and specifications containing GD&T.
  • Familiarity with technologies and methods used to define how products are to be manufactured, how to conduct analysis, and meeting quality and compliance standards.
  • Extensive experience with transferring multi-disciplinary products from development to production.
  • Experience in identifying tooling, along with the appropriate operating conditions (speeds and feeds).
  • Additional qualifications as outlined in full job description.

TOMZ Corporation is an Equal Opportunity Employer

Join our team in CT! TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated CNC Programmer to join our organization...

Berlin, CT
Posted 16 hours ago

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.


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 m...

Our Mission

To enhance the lives of patients by sustainably manufacturing innovative medical devices for leading OEMs around the globe.

Group photo of the TOMZ Corporation team standing next to a white sports car with the blue and red TOMZ Corporation logo on it in front of the company's headquarters in Berlin, Connecticut.
Green and blue specialty screws that are created at the TOMZ Corporation for use in medical devices.

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.

X-ray showing two views of a spinal fusion that was done using hardware manufactured at TOMZ Corporation.
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.
Three women employees, two wearing blue shirts and one wearing a white shirt and blue latex gloves, stand at a table as they smile and perform quality control inspections on specialty screws and other manufactured parts.
Embrace Diversity
Our workforce is incredibly diverse by design. Individuals from different backgrounds offer valuable, unique perspectives. Diversity leads to innovation and open-mindedness.
Three employees, two wearing blue shirts and one wearing a red shirt, stand next to a microscope in the machine shop as they look closely at a manufactured part.
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.
An employee stands in front of a yellow background that says he's won the prize of a week's paid vacation and a $5,000 travel voucher as he holds onto an oversized check stating the same. Other employees in the audience cheer him on.

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

2 Videos

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.