Supplier Quality Assurance Specialist
3 weeks ago
At Accuray, we are committed to making a direct and powerful impact on the lives of cancer patients every day. As a Supplier Quality Engineer, you will play a crucial role in helping us achieve this goal by ensuring the quality of purchased materials and suppliers.
Key Responsibilities:
- Maintain the approved supplier list (ASL) for material and service suppliers.
- Evaluate and influence the selection of new suppliers for quality, delivery, and cost.
- Plan, conduct, and document supplier audits and assist or lead audit program planning.
- Negotiate and ensure adherence to supplier quality agreements.
- Update supplier qualification records, including surveys and certifications.
- Review and update supplier risk evaluations.
- Review engineering change orders (ECOs) and procurement specifications for supplier manufacturability.
- Set up supplier and part information in the enterprise resource planning (ERP) system.
- Request and review supplier part qualification information, including first article inspection reports (FAIRs) and other production part approval (PPAP) information.
- Setup, review, and update incoming inspection plans.
- Investigate purchased material defects encountered during inspection, assembly, testing, installation, and servicing.
- Review and trend supplier defect data and issue supplier defect notices (SDNs).
- Issue, review, and follow-up on supplier corrective actions requests (SCARs).
- Prepare materials for and records of supplier review board (SRB) meetings.
- Update standard operating procedures (SOPs), work instructions (WIs), and job aids.
Requirements:
- Highly organized and driven performer with a demonstrated track record of achievement delivering improved products and services for customers and internal stakeholders with urgency.
- Bachelor's Degree in one of the following (or similar) engineering disciplines: electrical, industrial, manufacturing, mechanical, quality.
- 5+ years' experience working with suppliers in a highly regulated manufacturing environment operating within an ISO 9001, ISO 13485, 21 CFR 820, MDSAP, or similar quality system.
- Strong ability to influence others within and outside the company using well-developed verbal and written communication skills.
- Strong analytical, critical thinking, and problem-solving skills.
- Ability to consistently work on-site and travel between multiple Madison-area facilities.
- Ability to travel to local, domestic, and international suppliers as needed - sometimes with short notice (estimated 5-20%).
Preferred or Desired Qualifications:
- Prior supplier management experience.
- Experience working with complex, software-driven, electro-mechanical systems.
- Familiarity with state-of-the-art processes used to manufacture RF and X-ray generation/detection/imaging subsystems, printed circuit assemblies, high-performance computers, cables/wire harnesses, and/or fabricated/machined components.
- Prior experience planning and reviewing purchased part qualification activities using PPAP or similar processes.
- Lead auditor certification with prior supplier auditing experience.
- Proficient with ERP and quality system software like SAP and Master Control.
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