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23 Sep 2020

Full-Time Supplier Quality Engineer

Accuray Inc. Madison, Wisconsin, United States

Job Description

Summary: 

Accuray aspires to set high goals for our Quality department and team members. Our Quality Systems environment ensures that the design, development, manufacturing, and support of medical devices meet the requirements of ISO 13485, 21 CFR Part 820, and other applicable regulations and standards. Supports all phases of product lifecycle, including Supplier Assessment and Monitoring, Forward Production, Product Changes and Upgrades, and Customer Complaints.

The Quality Engineer will represent Quality Assurance on  product and process development teams and participate in development, review and approval of Product Quality, Supplier development, Supplier Quality surveillance, Supplier Quality improvement plans, Manufacturing Project plans, and process assignments may be used for development or production support on an individual basis.

Essential Duties and Responsibilities:

  • Manage and Maintain the Corporate Approved Supplier List (ASL) with focus on direct materials and services.
  • Maintain a culture of quality as it pertains to Accuray products and services.
  • Assess Existing and Proposed Suppliers’ Quality Attributes
  • Review engineering changes to ensure clarity and adequacy of Supplier Quality attributes
  • Review and Approve proposed First Article Inspection protocols (FAI’s)
  • Manage the Receiving Inspection Function at Madison Location(s)
  • Ensure the development of an Annual Supplier Audit Schedule
  • Use of quality analytics to perform on-site, and remote audits of Critical Suppliers, together with Supply Chain and Engineering
  • Develop Supplier quality best-practice; improve Supplier product quality by making recommendations for change
  • Contribute to development of SCOPQ, cost of quality metrics and back-charge program
  • Issuance and reporting of Supplier Corrective Action Requests (SCAR’s)
  • Work Collaboratively with the Sourcing Team in the areas of Evaluating, Auditing, and Managing Suppliers
  • Monitor and report supplier/manufacturing quality performance metrics and trends
  • Schedule and Lead the Supplier Review Board Meetings (SRB).
  • Ensure adherence to quality agreements with key suppliers.
  • Champion improvement activities in conjunction with suppliers and internal stakeholders.

Qualifications:

a. Required

  • Bachelor’s Degree in Quality Engineering (or other Engineering disciplines)
  • 3 to 5+ years’ experience in Quality Assurance or Quality Engineering in the medical device industry
  • Competency in the FDA Medical Device Quality System Regulations and ISO 13485
  • Strong verbal and written communication skills
  • Critical Thinking and Problem-Solving mindset
  • Use of analytical data to make business decisions
  • Be customer-focused, drive operational excellence, build trusting relationships, and work with a sense of urgency
  • Ability to work together with relevant teams and departments to improve products and services

b. Preferred or Desired

  • ASQ certification or equivalent
  • Working knowledge of PPAP or similar supplier management tools
  • Experience in the manufacture of high voltage electrical systems, high power microwave devices or linear accelerators

EEO Statement

At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top — and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin – including individuals with disabilities and veterans.

How to Apply

Please apply via the provided Workday link

Job Types: Full-Time.

Job expires in 14 days.

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