Quality Engineer

Join us as a Quality Engineer at Katalyst CRO to support the launch of a new medical device product into production at our onsite manufacturing facility in Devens, MA. The role focuses on process validation, risk management, and ensuring compliance with medical device quality and regulatory standards.

• 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.

Mid-Senior level

Contract

Quality Assurance

Pharmaceutical Manufacturing