Description

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)
Participate in 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 periodic management reviews
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 Assurance group
Support internal and third-party audits (FDA, Notified Body)
Participate in Material Review Board (MRB) meetings
Manufacturing Line Transfers
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 Quality point of contact with CMs, and provide remote and off-site support on matters related to Quality
Other duties as assigned

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 Employer

Shockwave Medical

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Sr. Supplier Quality Engineer