Senior Director of Quality Operations and Supplier Quality

1 month ago

Santa Clara, California, United States Shockwave Medical Full time
Job Summary

The Senior Director of Quality Operations and Supplier Quality will provide leadership for the organization's Quality Operations and Supplier Quality groups. This role will participate in decisions on scope of work, risk management, length of tasks and compliance pathways, as well as optimization of manufacturing processes. The Senior Director will participate in design changes to provide quality strategy and guidance for revised specifications and is expected to provide developmental and technical guidance to the team. The Senior Director will also develop and implement procedures and systems to assure Shockwave Medical complies with applicable regulatory standards such as:
  • 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
Key Responsibilities
  • 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.
Requirements
  • 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.

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