Supplier Quality Engineer - Katalyst Healthcares & Life Sciences
Des Plaines, IL 60016
About the Job
Responsibilities and Requirements:
- Engineering, Technical, or Scientific discipline with minimum of 4-8 years of related experience is required, preferably within a regulated environment (e.g., FDA regulated).
- Good Experience in IQ / OQ / PQ processes at Mfg. sites
- Quality Engineering/Design or Process Excellence/Lean experience is preferred.
- Collaborate to complete Component Qualification, document evidence.
- Prepare Protocols, works requests & reports for Supplier Qualified components
- Collaborate with suppliers to collect evidence and/or develop Production Part Approval Process (PPAP)
- Knowledge of the QSR, Design Controls, and ISO quality requirements.
- Experience conducting Process / Design Failure Mode Effects and Analysis
- Understand and interpret all manufacturing audits, including ISO 13485 and other industry standards.
- Conduct supplier quality control audits on a regular basis to ensure vendors and their supplies remain in compliance with company and federal manufacturing and production standards.
- Experience in CAPA execution and Non-Conformance management
- Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Purchasing)
- Mechanical product knowledge is preferred.
- Problem-solving techniques including 8D, root cause analysis, and cause and effect analysis.
Source : Katalyst Healthcares & Life Sciences
