Join Us on Our Mission to Improve Patients' Lives.

Full Time
Berlin, CT
Posted 1 month ago

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist II 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 manufacturing 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, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • 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, Anodize/Passivation Lines.
  • Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
  • Ability to setup basic legacy components 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, etc.
  • Regularly and as prescribed, perform preventive maintenance of equipment.
  • Drive problem solving activities for basic 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.
  • 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 preferred.

Experience

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

Preferred Skills/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.
  • Demonstrated understanding of the usage and care of mechanical equipment and inspection processes.
  • Ability to use basic hand-held tools to perform preventive maintenance 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.
  • Strong verbal and written English language communication skills.

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 30 pounds while moving tooling or tool holders. 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.

First Shift: Mon-Fri 6 am to 4:30 pm
50 hours

Job Features

Job Category

First Shift

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist II to join our organization. TOMZ offers competitive compensati...

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

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.
  • 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.
  • 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 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.

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 20 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.

Job Features

Job Category

Second Shift

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...

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

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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.