Quality Assurance Engineer

AP Professionals
Published
May 9, 2019
Location
Rochester, New York
Job Type
Street Address
500 Linden Oaks

Description

AP Professionals has partnered with a medical device imaging solutions provider seeking a Quality Assurance Engineer to join their growing Rochester team. The Quality Assurance Engineer will report to the VP of Operations, and need to be able to handle an “all hands-on-deck” environment. Responsibilities include audits; complaint response; and corrective and preventative actions. Previous medical device industry experience is an absolute must, no exceptions.

Responsibilities

  • Direct and document complaint and corrective and preventative action investigations
  • Perform and record equipment calibrations
  • Assist in 510K submissions
  • Issue unique device identification (UDI) registrations
  • Prepare quality metrics reports
  • Conduct and report on internal audits
  • Manage onsite inspections, including ISO, FDA, and customers
  • Support engineering change notice approvals, verifications, and validations
  • Manage QMS documentation and safety data sheet change controls

Education

  • Bachelor’s in Applied Science or a related technical field required; will consider equivalent experience

Experience

  • 5+ years’ related technical or quality experience required

Knowledge, Skills, Abilities, and Other Characteristics

  • Knowledge of ISO 13485, OSHA, and FDA regulations required
  • Proficiency with MS Office (Excel and Word) required
  • Ability to liaise between departments and disciplines required
  • Strong organization and prioritization skills required
  • Ability to lift and/or move up to 30 pounds
Apply
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