Lead Supplier Quality Auditor - 27239

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

Qualifications

• 8 years of relevant experience in Quality, Management, or Engineering
• BS Degree in Engineering or relative area.
• LEAD QUALITY AUDITOR CERTIFICATION Required
• Experience in medical device industry preferred
• Experience working onsite developing suppliers preferred
• Experience conducting supplier audits and internal audits preferred
• Demonstrated collaboration, negotiation, and conflict resolution skills
• Demonstrated ability to lead, champion change, and execute strategies to meet goals
• Critical thinking and strong analytical skills
• Comprehends production/process controls, FDA verification/validation, problem solving, & root cause
• Comprehends quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts
• Comprehends statistics and use of Minitab software: SPC, MSA, DOE, and Process Capability

Pay: $70.00 - $72.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

License/Certification:

• Lead Quality Auditor (Required)

Work Location: In person

Salary : $70 - $72