Job Boards Template

Search Jobs

Supplier Quality Auditor

Redmond, Washington 98052 | Contract

Post Date: 02/05/2018 Job ID: 18036 Industry: Software

Position Title:  Supplier Quality Auditor

Position Description:  Protingent Staffing has an exciting contract opportunity with our client in Redmond, Washington. The role is responsible for the coordination and implementation of on-site and documentation audits, related CAPA and communication of evaluation results to key stakeholders.

Job Requirements:
  • Lead the planning, leading, executing, and post-processing of supplier QMS and process audits.
  • Identify and communicate issues that may impact product quality, system gaps or cause interruptions in business continuity.
  • Prepare and complete audit reports and communicate with internal teams and suppliers within a timely manner per local procedural requirements.
  • Ensure audit findings are properly contained and suppliers implement proper corrective actions that rectify identified gaps. 
  • Maintain supplier audit files and ensure all files are properly filed into the proper systems (i.e. Supplier Audit Management (SAM)
  • 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
  • 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

Job Qualifications:
  • Bachelor of Science in engineering, or engineering related discipline required
  • Knowledge of Quality Management Systems, FDA 21 CFR Part 820, ISO13485 and/or ISO9001 required
  • ASQ or RABQSA certification preferred (i.e. CQE, CQA, Lead Auditor)
  • ISO-13485 Lead Auditor certification or equivalent preferred
  • Experience supporting HWSW engineers Excellent customer service skills.
  • Education: AA in Electronics or better.
  • 3 years of relevant experience in Quality, Management, or Engineering
  • 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
  • Strong communication skills, verbal and written
  • Excellent time management and organization skills, with high emphasis on attention to detail
  • Advanced working knowledge of Microsoft Word, Excel, Outlook, PowerPoint, Visio, and Adobe 
  • Travel is approximately 50%
  • Regular travel to supplier facilities required Must be able to travel internationally.

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.

Benefits Package: Protingent offers competitive salary, 100% paid health insurance, education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.

Chris Walsh

Since 2013 I have been able to meet a lot of bright minded and interesting people while recruiting for Protingent. I specialize in hardware and software product development engineers. My recruiting style is to build a strong, lasting relationship as I help you achieve your career goals. I am a straight forward open minded individual and treat others as I wish to be treated. I enjoy sports, food and wines. Let’s get started today.

Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: