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 Supplier Quality Engineer II performs work with general supervision to provide and implement solutions to defined problems and assignments. The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues. The Supplier Quality Engineer II 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.
- Participate in the planning, scheduling, execution, and reporting of supplier audits.
- Participate in the initiation, issuance, review, and approval of Supplier Corrective Action Reports (SCARs).
- Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions.
- 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 Supplier Scorecards.
- 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.
- Manufacturing Line Transfers
- Assist in defining requirements and generating documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs).
- Assist in planning and providing on-site and off-site training to CMs on product inspection and testing.
- Monitor product quality and production rates at CMs and assist in the resolution of production line issues.
- Other duties as assigned
Requirements
- BS degree in a related engineering discipline and 3+ years of related experience, or MS degree in a related engineering discipline.
- Experience in the medical device industry is strongly preferred.
- Knowledge 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.
- Knowledge of 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 10% of the time.
Market Range: $86,000 - $107,000
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: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards.
EEO Employer
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