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 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.
  • Additional responsibilities as outlined in the full job description.

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.

***Additional qualifications as outlined in the full job description.

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