What are the responsibilities and job description for the Quality Engineer position at Katalyst CRO?
Job Summary
- Medical Device Quality Engineer responsible for supporting the launch of a new medical device product into production at an onsite manufacturing facility in Devens, MA.
- The role focuses on process validation, risk management, and ensuring compliance with applicable medical device quality and regulatory standards through cross-functional collaboration.
- Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.
- Perform and analyze IQ, OQ, and PQ qualifications along with other validation activities.
- 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.
- Analyze validation data and recommend process optimizations based on results.
- Collaborate with Quality, Engineering, and Manufacturing teams to resolve production issues and drive continuous improvement.
- Write, maintain, and control SOPs, work instructions, and process documentation to support consistent production and regulatory audits.
- Maintain validation and quality documentation in compliance with internal procedures and applicable regulatory requirements.
- Minimum of 10 years of experience in process validation within the medical device industry (pharmaceutical experience not applicable).
- Hands-on experience executing IQ, OQ, PQ, and conducting FMEAs.
- Orthopedic medical device experience preferred.
- Strong understanding of medical device regulatory and quality standards.
- Proven ability to develop validation protocols and reports while maintaining controlled documentation.
- Self-starter with strong problem-solving skills and the ability to work independently and collaboratively in a fast-paced, onsite manufacturing environment.