Lead Supplier Quality Auditor

California, San Jose

Post Date: 05/31/2018 Job ID: 11700 Industry: Engineering

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Lead Certified Quality Auditor for a 6 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 Description (Principle Duties and 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


3 years of relevant experience in Quality, Management, or Engineering
BS Degree in Engineering or relative area.
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
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