Senior Supplier Quality Engineer

1 week ago


Santa Clara, California, United States Shockwave Medical Full time
Job Title: Sr. Supplier Quality Engineer

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our company aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Job Summary

The Sr. Supplier Quality Engineer performs work with general supervision to provide and implement solutions to broad problems and accomplishes complex assignments. The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues.

Key Responsibilities
  • Supplier Management: Partner with Procurement, R&D, Operations, Quality, and Suppliers in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations.
  • Manufacturing Support: Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
  • Manufacturing Line Transfers: Partner with cross-functional teams to define requirements and generate documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs).
Requirements
  • BS degree in a related engineering discipline and 5+ years of relevant experience, or MS degree in a related engineering discipline and 3+ years of relevant experience.
  • Experience in the medical device industry is strongly preferred.
  • Strong understanding of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems.
  • Strong technical writing skills.
  • Effective communication skills across all levels of the organization.
Benefits

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

  • Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match.
  • Short-Term and Long-Term Disability, and Life Insurance.
  • Employer contribution toward Health Savings Account (HSA).
  • Competitive PTO balance.


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