Job Description
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.
Job Tags
Full time,