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Quality Assurance Specialist, Sr

A-dec

Newberg, OR · Senior

Listed on A-dec’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

This role manages quality management systems and regulatory compliance for a medical device manufacturer, ensuring adherence to FDA and international standards through internal audits, corrective action programs, and cross-functional coordination. It suits someone with quality assurance experience in regulated industries who is comfortable with compliance documentation and comfortable leading others.

Our summary, not A-dec’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • Bachelor's degree in business, science, or engineering
  • At least four years of QMS administrator experience
  • Working knowledge of FDA, CMDR, EUMDR, ISO 13485, and MDSAP standards
  • Proficiency in Microsoft Office
  • Strong technical writing and communication skills
  • Impeccable attention to detail and organizational skills

Nice to have

  • Experience as a lead internal auditor of Quality Management Systems
  • Familiarity with enterprise quality management system (eQMS) software platforms

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