Senior Quality Assurance Engineer Job at SSi People, Murrysville, PA

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  • SSi People
  • Murrysville, PA

Job Description

Responsibilities:

  • facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs.
  • Analyze existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.
  • Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
  • Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes.

Qualifications:

  • BS in Engineering or a related field. MS preferred.
  • 6+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry.
  • 2+ years experience with a MS or higher.
  • Extensive hands on experience with the ISO 14971 standard.
  • Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.

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