Quality Engineer - Katalyst Healthcares & Life Sciences

Engineering, Technical, or Scientific discipline with minimum of 5-8 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 regularly to ensure vendors and their supplies comply 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.