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Validation Quality Engineer
2 months ago
- Join a dynamic team at a prominent Global Medical Device Manufacturer.
- Play a vital role in collaboration with Leadership to enhance quality processes.
Our client is a leading global manufacturer specializing in the assembly of medical devices, boasting over 60 years of industry experience and a presence in more than 10 locations worldwide. With significant growth anticipated at their New England site, they are poised for exciting developments in the near future.
Job Overview
The primary responsibilities of the Quality Validation Engineer include:
Development and Execution of Validation Protocols
- Create and execute validation master plans, protocols, and reports for equipment, processes, and software.
- Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for both new and existing equipment.
- Ensure all validation activities adhere to FDA, ISO 13485, and other pertinent regulatory standards.
- 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 risk mitigation strategies.
- Identify and implement process improvements to enhance operational efficiency and product quality.
- Remain informed about industry trends, regulatory updates, and best practices in validation engineering.
Qualified candidates will be contacted promptly and provided with a comprehensive job description for the position. Our client is committed to fostering a diverse workplace and encourages applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.
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.
- Experience in metrology, particularly with Calypso (Zeiss CMM software).
- Familiarity with Minitab.
- Exposure to injection molding processes.
The organization provides:
- Competitive base salary.
- Bonus potential.
- Comprehensive benefits package.
- Opportunities for career advancement within the company.
