| Medical Device Quality Engineer :: Devens, MA Onsite at Devens, Massachusetts, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2959069&uid=01049f7a438e4dc7af81ee86b2f9d8b6 From: Praveen Nagar, Vyze inc [email protected] Reply to: [email protected] Job Description -Job Title: Medical Device Quality Engineer Location: Devens, MA (Onsite, 5 days/week) Start Date: December 2025 Engagement: Contract-to-Hire (Initial ~6 months)Overview Seeking an experienced Medical Device Quality Engineer to support the launch of a new product into production. The role focuses on process validation and ensuring compliance with medical device quality and regulatory standards.Key Responsibilities Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes. Lead PFMEA sessions to identify, assess, and mitigate process and product risks. Design, validate, and verify test methods to ensure product quality and regulatory compliance. Perform and analyze IQ, OQ, PQ qualifications and other validation activities. Collaborate with cross-functional teams (Quality, Engineering, Manufacturing) to drive continuous improvement and resolve production issues. Analyze validation data and recommend process imizations based on findings. Write and maintain SOPs, work instructions, and process documentation to support repeatable, high-quality production and regulatory audits. Maintain validation and quality documentation in accordance with internal procedures and applicable regulatory requirements.Required Qualifications 10+ years of experience in process validation (medical device experience required; not pharma). Hands-on experience with IQ, OQ, PQ and FMEAs. Orthopedic device experience preferred. Strong understanding of regulatory compliance and quality standards applicable to medical devices. Proven ability to develop validation protocols/reports and maintain controlled documentation.Desired Soft Skills Self-starter with excellent problem-solving skills. Ability to work independently and collaboratively in a fast-paced manufacturing environment.Additional Notes Role is onsite at the Devens, MA facility and requires regular presence (5 days/week). Position is expected to start December 2025. Contract-to-hire engagement; initial assignment approximately 6 months with potential for hire. Keywords: Massachusetts Medical Device Quality Engineer :: Devens, MA Onsite [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2959069&uid=01049f7a438e4dc7af81ee86b2f9d8b6 |
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| 08:51 PM 01-Dec-25 |