Sr. Director, Quality Operations and Supplier Quality

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.

• ISO 13485 - Medical Devices - Quality Management Systems
• ISO 14971 - Medical Devices - Application of Risk to Medical Devices
• 21 CFR Part 820 - Quality System Regulation
• 21 CFR Part 803 - Medical Device Reporting
• FDA Current Good Manufacturing Practices (CGMPs)
• EU MDR - European Medical Device Regulation (MDR)
• Council of the European Communities Directive 93/42/EEC - Medical Device Directive
• MDSAP and other relevant geography regulations

• Quality Operations
  • Directly responsible for ongoing management and improvements to the following Quality Operations activities:
    • Quality Control and Engineering support for manufacturing and operations
    • Incoming inspection and Final product acceptance activities
    • Complaints investigation
    • Document Control
    • Equipment Control
  • Collaborate with R&D and Manufacturing engineering on process improvement projects.
  • Interface with Design Assurance, R&D and Manufacturing to interpret Engineering requirements, drafting, reviewing and approving inspection and manufacturing related documentation.
  • Support new product design transfer into manufacturing.
• Supplier Management
  • Oversee and manage the execution of Supplier Quality responsibilities such as Supplier Audits, Supplier Qualifications, Supplier Corrective Actions (SCARs), Supplier Change Assessments (SCAs), Non-conformance Reports (NCRs) for raw materials/components.
  • Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity.
  • Support component qualification projects in collaboration with key business partners and the supplier's applicable functional groups.
• Manufacturing Line Transfers
  • Define Quality requirements and plan tasks needed to transfer manufacturing lines or manufacturing processes to Contract Manufacturers or other SWMI sites.
  • Support the cross-functional team by contributing to planning, allocating technical resources, assisting with technical issues, and providing guidance on transfers.
  • Define processes to monitor product quality and production rates at CMs and to act when issues arise.
• Management
  • Identify resource needs and hire as dictated by business needs.
  • Responsible for direct supervision of the Quality Operations and Supplier Quality Leadership teams including hiring, coaching, training and development of subordinates.
  • Collaborate with business partners to define and document processes affecting cross-functional teams (e.g.: Design Assurance, R&D, Manufacturing.)
  • Collaborate cross-functionally in the interpretation of regulatory and engineering requirements and educate and influence others on those requirements.
  • Communicate critical issues to upper management and escalate accordingly.
• Plan, manage, and oversee the assessment and implementation of process changes (e.g.: capacity expansions, equipment) at suppliers or at Shockwave Medical Inc. (SWMI)
• Define KPIs and metrics for Operations and Supplier Quality and create/define systems to support the efficient collection and analysis of data for such KPIs and metrics.
• Assist with risk management process maintenance.
• Lead teams to investigate, perform root cause analysis and develop corrective actions.
• Maintain compliance of Operations and Supplier Quality activities to Business Unit, JnJ sector and corporate requirements.
• In conjunction with the VP, Quality, plan, develop, track and report on department goals and objectives, budget, hiring, and training and development.
• Support ongoing Quality System and Compliance activities (CAPAs, NCRs, Service Order Requests, Audits, Standards Gap Assessment etc.)
• Define and execute plans for post commercial Design Changes, Supplier changes, QMS integration and automation to achieve high standards of Quality.
• Other duties as assigned.

• BS degree in a related engineering discipline and 15+ years of related experience, or MS degree (preferred) in a related engineering discipline and 12+ years of related experience.
• 5+ years of experience managing others and leading teams.
• Strong understanding of cGMP, FDA 820 QSR, ISO 13485.
• Prior experience in product design transfers/ manufacturing line transfers.
• Effectively supervise, manage, and develop teams.
• Successfully work in a fast-paced environment while managing multiple priorities.
• Initiate and/or lead projects and successfully drive projects to completion.
• Strong decision making with minimal information while maintaining an understanding of risks and outcomes.
• Strong leadership, analytical and problem-solving skills.
• Excellent communication skills
• Ability to travel up to 20% of the time.
• Relevant certifications (eg: Lead Auditor, Six Sigma, Project Management, CQE) are a plus.
• Ability to speak Spanish is a plus.

Market Range:

$221,000 - $277,000
Exact compensation may vary based on skills, experience, and location.

Benefits
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