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. 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.

Essential Job Functions

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
• Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the next management level
• Plan, schedule, execute, report, and follow-up on supplier audits
• Initiate, issue, review, and approve Supplier Corrective Action Reports (SCARs)
• Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions
• Own, manage, and drive to completion Supplier Change Assessments (SCAs)
• Lead component qualification change projects in collaboration with key business partners and the supplier's applicable functional groups
• Compile, analyze, and summarize supplier performance data for Supplier Scorecards
• Assist in preparing Supplier Quality Agreements

Manufacturing Support

• Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs)
• Initiate, review, and approve Document Change Orders (DCOs)
• Provide technical support and guidance to the Quality Control group
• Collaborate with Manufacturing Engineering on process improvement projects
• Investigate customer complaints and document investigation findings
• Participate in internal and third-party audits (FDA, Notified Body)
• Participate in Material Review Board (MRB) meetings
• Partner with cross-functional teams to define requirements and generate documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs)
• Plan and provide on-site and off-site training to CMs on product inspection and testing
• Act as the primary point of contact with CMs, and provide remote and off-site support on matters related to Quality
• Review and approve CM validation protocols and reports and risk documentation
• Monitor product quality and production rates at CMs and assist in the resolution of production line issues

Requirements

• BS degree in a related engineering discipline and 5+ years of related experience, or
• MS degree in a related engineering discipline and 3+ years of related 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), Six Sigma, Lean
• Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus
• Ability to travel up to 20% of the time

Market Range: $115,759 - $130,050
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 Employer