Sr. Supplier Quality - Medical Device - Irvine

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.