Quality Engineer

  • Contract

Company Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

 

Job Description

Roles & Responsibilities:

  • Quality Engineer withs strong medical device experience and PRODUCT QUALITY. MUST have experience with Class III/Implantable medical device(s).
  • Experience maintaining/working within an ISO 13485 Quality Management System (QMS)
  • Experience with CAPA Process.
  • CE Marking experience.
  • Good team player works cross functionally with Engineering and Quality.
  • Solid understanding of regulatory standards & requirements (13485, MDR and FDA).
  • Experience managing Quality Management System documents and systems.

Additional Information

All your information will be kept confidential according to EEO guidelines.