Quality Systems Engineer

Quality Systems Engineer – Katalyst CRO

Apply for the Quality Systems Engineer role at Katalyst CRO
.

• Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc.
• Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending.
• Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.).

• Bachelor's Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 3-6 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems.
• Must have Medical Device experience in most recent roles.
• A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR.

Mid-Senior level

Contract

Quality Assurance

Pharmaceutical Manufacturing

Bedford, MA