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Quality Assurance Supplier Engineer

2 months ago

Madison, Wisconsin, United States Accuray Full time
Empower Lives. Enhance Health. Join the Battle Against Cancer.

At Accuray, we have a profound and direct influence on the lives of individuals battling cancer, striving to help them lead longer and healthier lives. Our dedication to groundbreaking innovation presents a unique opportunity: to transform the fight against cancer by developing, launching, and supporting advanced treatment delivery systems and software that provide renewed hope and health to cancer patients and survivors globally.

Accuray specializes in the development, manufacturing, and distribution of radiotherapy systems designed for alternative cancer treatments. Our radiation therapy solutions aim to make treatment more efficient, safer, tailored, and effective, ultimately enabling patients to enjoy improved quality of life.

Position Overview

Role Summary:

The Supplier Quality Engineer is an integral part of the quality assurance team, responsible for planning and executing activities related to the evaluation, oversight, and management of sourced materials and suppliers. This role involves collaboration across various departments including engineering, procurement, manufacturing, service, and other quality teams to support all stages of the product lifecycle, from initial development to customer support.

Key Responsibilities:
  • Maintain the Approved Supplier List (ASL) for material and service providers.
  • Assess and influence the selection of new suppliers based on quality, delivery, and cost metrics.
  • Plan, execute, and document supplier audits while assisting or leading audit program development.
  • Negotiate and ensure compliance with supplier quality agreements.
  • Update supplier qualification documentation, including surveys and certifications.
  • Review and refresh supplier risk assessments.
  • Analyze engineering change orders (ECOs) and procurement specifications for supplier manufacturability.
  • Establish supplier and part data in the enterprise resource planning (ERP) system.
  • Request and evaluate supplier part qualification documentation, including first article inspection reports (FAIRs) and other production part approval (PPAP) materials.
  • Develop, review, and update incoming inspection protocols.
  • Investigate defects in purchased materials identified during inspection, assembly, testing, installation, and servicing.
  • Analyze and track supplier defect data, issuing Supplier Defect Notices (SDNs) as necessary.
  • Generate, review, and follow up on Supplier Corrective Action Requests (SCARs).
  • Prepare materials and documentation for Supplier Review Board (SRB) meetings.
  • Revise standard operating procedures (SOPs), work instructions (WIs), and job aids.
Qualifications:

a. Required Skills
  • Highly organized and results-driven professional with a proven history of enhancing products and services for customers and internal stakeholders with urgency.
  • Bachelor's Degree in relevant engineering disciplines such as electrical, industrial, manufacturing, mechanical, or quality engineering.
  • 5+ years of experience collaborating with suppliers in a regulated manufacturing environment adhering to ISO 9001, ISO 13485, 21 CFR 820, MDSAP, or similar quality systems.
  • Exceptional ability to influence stakeholders within and outside the organization through strong verbal and written communication skills.
  • Excellent analytical, critical thinking, and problem-solving capabilities.
  • Willingness to work on-site and travel between multiple facilities as required.
  • Ability to travel to local, national, and international suppliers as needed, sometimes on short notice (estimated 5-20%).
b. Preferred Skills
  • Experience in supplier management.
  • Familiarity with complex, software-driven, electro-mechanical systems.
  • Knowledge of advanced manufacturing processes for RF and X-ray generation/detection/imaging subsystems, printed circuit assemblies, high-performance computers, cables/wire harnesses, and/or fabricated/machined components.
  • Prior experience in planning and reviewing purchased part qualification activities using PPAP or similar methodologies.
  • Lead auditor certification with previous supplier auditing experience.
  • Proficiency in ERP and quality management software such as SAP and Master Control.
To qualify for this position, candidates must be able to provide proof of authorization to work in the country they are applying for on a permanent basis without sponsorship.

EEO Statement

At Accuray, our commitment to patient-first outcomes fosters an inclusive and collaborative work environment where the best ideas thrive, and everyone contributes to their advancement. We value diversity in the professional and personal backgrounds of our employees, as this variety enriches every team, project, and workday. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, including individuals with disabilities and veterans.

Accuray Pay Transparency Statement:

Accuray's pay ranges vary based on work location. As part of the total compensation package, this role may be eligible for the Accuray Bonus Plan or a role-specific commission/bonus, as well as annual refresh stock grants. Recruiters can provide more details during the hiring process. Each candidate's compensation offer will be based on multiple factors including, but not limited to, geography, experience, skills, future potential, and internal pay parity.