Supplier Engineering

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Job description

Responsibilities and Requirements:

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 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.

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