Sr. Audit Supplier Quality Engineer

Description

Responsibilities related to compliance:* Complete risk-based audits of suppliers per Stryker's required cycle times to ensure conformance and compliance * Lead timely and compliant Operations audits as required and directed by the internal audit program* Provide compliant records for FDA, ISO, Corporate, Internal, 2nd party, and Operations audits* Ensure supplier Quality Management Systems comply with applicable FDA and ISO regulations and requirements* Identify and write findings and observations during evaluations and drive timely closure of NCs through the CAPA system* Work with suppliers to quarantine all suspect and non-conforming material, as required* Issue supplier corrective action requests, as required, and drive suppliers to identify, correct, and prevent the root cause* Participate in supplier audits, supplier evaluation, and supplier monitoring as required* Train and educate suppliers on GMP, regulatory requirements, and Stryker expectationsResponsibilities related to sustainment:* Evaluate processes, write audit reports, write non-conformances, and store records per Document Control requirements* Ensure a timely supply of conforming components and products to Stryker through process sustainment* Root cause analysis of processes related manufacturing defects and warranty concerns* Identify and communicate supplier initiated changes and ensure the suppliers follow change control requirements* Serve as a subject matter expert for supplier evaluations, share expertise within the division and site Responsibilities related to development:* Foster strong relationships with Stryker's supplier-partners acting as an extended enterprise * Complete on-site audits of suppliers' Quality Management Systems through risk based processes audits* Drive improvement by identifying and communicating ineffective or inefficient Quality Management System processes* Report non-conformance and performance data to highlight systemic supplier issues* Support the creation and execution of supplier development plans by identifying potential process improvements* Drive continuous improvement actions within supplier processes to reduce part related defects (DMP)* Support strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selection* Communicate "lessons learned" from the supply base to R&D for incorporation into next generation designs