Quality Assurance Specialist

  • Performs incoming inspections of components, supplies, and tools.
  • Assists with product release testing of catheters and implants.
  • Performs in-process inspections to support manufacturing.
  • Ensures product & component testing / evaluation is conducted according to GMP and established internal standards.
  • Maintains/manages incoming inspection queue with minimal supervision.

POSITION RESPONSIBILITIES

  • Performs incoming inspections of materials/subassemblies; ensures that all inspections are performed per established procedures and specifications.
  • Ensures proper labeling and inventory transfer of dispositioned materials and finished goods.
  • Assists in performing investigations into product inquiries, nonconformances, process and product deviations.
  • Ensures controlled areas such as the QC lab and quarantine cage are kept neat and orderly and maintained per established procedures.

SKILLS & EXPERIENCE

Education:

High School Diploma; AA degree preferred.

Skills/Experience:

  • GDP, GMP, Word, Excel, measurement techniques, proficiency using measurement tools such as calipers, visual measurement systems, InSpec software, and working in a CER.
  • 2+ years of Quality Assurance or related experience in the medical device industry; well-developed written, oral and interpersonal skills.
  • Strong analytical skills, problem solving techniques, and the ability to work independently with minimal supervision. Must be detail oriented.

LOCATION

Menlo Park, CA