Quality Manufacturing Engineer Medical Device Winchester CT

2 days ago


Torrington, Connecticut, United States Michael Page Full time
Lead Quality Engineer Medical Device Manufacturing

Opportunity to contribute to a growing site of a Global Medical Device Manufacturer

About Our Client

Our client is a leading provider of assembly for medical devices, backed by over 60 years of excellence and 10 locations worldwide. Three locations are in New England, with the site in Torrington anticipating growth.

Job Description

The Lead Quality Engineer will develop and implement quality assurance strategies and processes for injected molded medical device components. Key responsibilities include:

  • Collaborating with production teams to ensure adherence to quality standards and regulatory requirements
  • Conducting root cause analysis and implementing corrective and preventive actions
  • Performing process validation and qualification activities
  • Driving continuous improvement initiatives
  • Supporting supplier quality management activities
  • Providing technical support and guidance to cross-functional teams
  • Participating in internal and external audits
  • Generating and maintaining quality documentation
Requirements

The successful Lead Quality Engineer will have:

  • Prior experience with validation protocols (IQ, OQ, PQ)
  • Root Cause Analysis experience
  • Independent time management and communication skills
  • Highly desirable: Metrology experience with Calypso (Zeiss CMM software) and Minitab experience
What's on Offer

The client offers a competitive base salary, bonus potential, and terrific benefits, with growth opportunities for advancement within the organization.



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