Ecocareers ยท 1 month ago
Medical Device Quality Engineer
Devens, MA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expConfidential company is 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.
Staffing & Recruiting
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
Qualification
Required
10+ years of experience in process validation (medical device experience required; not pharma)
Hands-on experience with IQ, OQ, PQ and FMEAs
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
Preferred
Orthopedic device experience
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase