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Sr. Supplier Quality - Medical Device - Irvine

Location: Irvine, California Salary: competitive
Sector: Medical Devices, Quality Assurance (QA), Operations, R&D, Regulatory Affairs (RA) Type: Contract

Job Function:

  • Responsible for ensuring compliance with all federal, state, local, and company regulations, policies, and procedures.
  • Responsible for defining supplier qualification requirements and drive deliverables to obtain supplier approval.
  • Works with suppliers to ensure quality system requirements are understood and successfully met.
  • Develop, update, and maintain inspection methods including validation activities.
  • Review and approve technical documents.
  • Lead special projects in collaboration with multi-functional team members.
  • Develop and provide trainings to enable seamless knowledge transfer of projects.
  • Support Nonconformance/CAPA/SCARS activities.

Qualifications:

Required Education/Skills/Experience:

  • Bachelor degree in engineering or science field with a minimum 4 years' experience in medical device manufacturing.
  • Knowledge and understanding of FDA and international regulatory standards for medical devices.
  • Strong documentation, communication and interpersonal relationship skills
  • Thorough understanding of root cause analysis principles, FMEA process, GR&R and process capability. Understanding statistical techniques, test method development
  • Collect, document, and analyze test data.
  • Develop and perform test method development and validation for equipment and product designs; experience with development of validation protocols
  • Ability to work independently without close supervision.
  • Previous medical device or pharmaceutical industry experience is preferred; Experience with Class III medical devices or experience with implantable devices a plus
  • Ability to read and interpret drawings.
  • Strict attention to detail.

Sthree US is acting as an Employment Business in relation to this vacancy.