Quality Assurance Validation Specialist

2 weeks ago


Torrington, Connecticut, United States Michael Page Full time
Join a Leading Global Medical Device Manufacturer

  • Be a vital member of a team that collaborates closely with leadership.
  • Contribute to the growth of a site with a strong reputation in the medical device industry.
About Our Client

Our client is a prominent global manufacturer specializing in the assembly of medical devices. With over 60 years of industry experience and a presence in more than 10 locations worldwide, they are poised for significant growth in the near future.

Position Overview

The primary responsibilities of the Quality Validation Engineer include:

Development and Execution of Validation Protocols
  • Create and implement comprehensive validation master plans, protocols, and reports for various equipment, processes, and software.
  • Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for both new and existing equipment.
  • Ensure that all validation activities adhere to FDA, ISO 13485, and other pertinent regulatory standards.
Risk Assessment and Management
  • Perform risk assessments utilizing methodologies such as FMEA (Failure Modes and Effects Analysis) to identify and mitigate potential hazards.
  • Work collaboratively with cross-functional teams to devise and implement effective risk mitigation strategies.
Continuous Improvement Initiatives
  • Identify and pursue opportunities for process enhancements to improve efficiency and product quality.
  • Remain informed about industry trends, regulatory updates, and best practices in validation engineering.
Application Process

Qualified candidates will be contacted promptly and provided with a detailed job description for the position.

Ideal Candidate Profile

The successful Quality Validation Engineer will possess:

Required Skills:
  • Experience with validation protocols (IQ, OQ, PQ).
  • Background in Root Cause Analysis.
  • Strong independent time management and communication abilities.
Highly Desirable Skills:
  • Experience in metrology, particularly with Calypso (Zeiss CMM software).
  • Familiarity with Minitab.
  • Exposure to injection molding processes.
What We Offer

The organization provides:
  • Competitive base salary.
  • Bonus potential.
  • Comprehensive benefits package.
  • Opportunities for career advancement within the company.


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