Sr. Supplier Quality Engineer

at  Shockwave Medical

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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.

POSITION OVERVIEW

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. The Sr. Supplier Quality Engineer participates in decisions related to scope of work, risk management, process improvements, material disposition, and the implementation of revised product specifications.

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
• Must be proactive, self-motivated, and able to work independently with minimal supervision
• Ability to work independently in a fast-paced environment while managing multiple priorities
• Experience in statistics (hypothesis testing, capability analysis, DOE, MSA, Gage R&R), Six Sigma, Lean
• Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus
• Able to lift objects weighing up to 25 lbs
• Ability to travel up to 20% of the time
  Market Range: $113,000 - $135,000
  Exact compensation may vary based on skills, experience, and location
  Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks -
  Core Benefits: 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
  Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
  EEO Employe

Please refer the Job description for details