Supplier Quality Auditor
11811 Willows Rd. NE Redmond, Washington 98052 | Contract
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.
- 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
- 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.