Lead Supplier Quality Auditor

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Lead Certified Supplier Quality Auditor for a 12 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

Position Responsibilities

Responsibilities related to compliance: 

• Complete risk-based audits of suppliers per 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 
• Ensure components, sub-assemblies, and devices meet all print specifications and applicable regulations 
• 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 expectations 

Responsibilities 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 through process sustainment 
• Root cause analysis of processes related manufacturing defects and warranty concerns 
• Communicate results of supplier evaluations to stakeholders and suppliers to ensure adequate responsiveness 
• 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 
• Support manufacturing transfer projects through the effective and efficient evaluation of suppliers and processes