| Medical Device Quality Engineer at Remote, Remote, USA |
| Email: [email protected] |
|
http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2957554&uid=ac84f56c305b4157b91506948870bee0 From: Priyanshi Baghel, Vyze inc [email protected] Reply to: [email protected] Job Description -Medical Device Quality Engineer (W2)Location: Devens, MAMedical And Pharma IndustryWork Arrangement: Onsite, 5 days/weekDuration: 6 months to Hire! Need Active LinkedInNeed Local Candidate We are seeking an experienced Medical Device Quality Engineer to support the launch of a new product into production. This role focuses on process validation and ensuring compliance with industry standards for medical devices. Key Responsibilities Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes. Lead PFMEA sessions to identify and mitigate risks. Design and validate test methods to ensure product quality and regulatory compliance. Collaborate with cross-functional teams (Quality, Engineering, Manufacturing) to drive continuous improvement. Analyze validation data and recommend process imizations. Maintain documentation in line with internal procedures and regulatory requirements. Write and maintain SOPs, work instructions, and process documentation for repeatable, high-quality production. Must-Have Qualifications 10+ years of experience in process validation. Medical Device experience (NOT Pharma). Orthopedic experience preferred. Expertise in FMEAs and IQ, OQ, PQ validation. Strong understanding of regulatory compliance and quality standards. Soft Skills Self-starter with excellent problem-solving skills. Ability to work independently and collaboratively in a fast-paced environment. Keywords: wtwo Medical Device Quality Engineer [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2957554&uid=ac84f56c305b4157b91506948870bee0 |
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| 01:33 AM 27-Nov-25 |