Medical Device Quality Engineer

Summary :
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.
Location: Devens, MA (Onsite, 5 days/week).

Roles & 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 optimizations 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.

Education & Experience :

• 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.
• Self-starter with excellent problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced manufacturing environment.