Sr Supplier Quality Engineer
$140,000–$150,000 year
On-siteKirkland, Washington, United States
Job Summary
Lead supplier audits, drive quality and process improvements, and manage supplier part qualifications using PFMEA, AQP, and PPAP techniques. Approve inspection sampling plans, oversee process validation reports via IQ/OQ/PQ, and maintain supplier KPIs to support scorecards. Execute root cause determinations and 8D corrective actions while utilizing six-sigma and lean manufacturing for continuous performance improvement. Act as the primary technical contact for supplier development and project management of audits, PPAP, and SCARs to meet internal deadlines. Maintain 100% compliance with the Medical Quality Management System. Requires frequent travel (20-30%) and extended hours when needed.
Required Qualifications
- Bachelor's degree in electrical engineering or material science, technical science or equivalent combination of education and directly relevant experience
- 8+ years' directly relevant experience, with prior experience in a FDA/cGMP or regulated environment
- Working knowledge of PPAP and IQ/OQ/PQ validation techniques
- Strong written and verbal communication skills
- Direct experience as a Manufacturing Engineer, Test Engineer, or Supplier Quality Engineer with the assigned commodities
- High level Excel or other statistical software skills for data analysis, problem solving and reporting
- Deep expertise in high-level quality systems best practices
- Ability to be a self-starter, seek new and better methods, and work with minimum supervision
- Capability to discern relevant facts and in turn, effectively resolve issues by making good decisions (compliance, quality, integrity, ethics, and critical thinking ability)
- Ability to be flexible in a fast-paced goal-oriented environment
- Demonstrates the understanding of deadlines and time limits, ability to accomplish goals, and the desire to win
- Extended/overtime hours when needed
- Frequent travel is required, 20%-30%
- Applicants must be eligible to work for any employer in the U.S.
Desired Qualifications
- 8+ years of experience in FDA/regulated environment
- Team leadership and project management experience
- Contract manufacturing support/ PCBA manufacturing support
- Experienced with six-sigma and lean manufacturing techniques
- Direct experience working with injection molding, plastic film welding/bonding, over-molded cables, and/or Wire harness assembly
- Ability to translate quality improvements to cost savings
- Certified quality auditor
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