Open Positions


« Back To All Positions

San Francisco Bay Area, CA

  • Quality Compliance Manager

    Position Overview

    The Quality Compliance Manager shall be responsible for ensuring compliance to regulatory
    requirements. The Quality Compliance Manager shall support international regulatory
    submissions for product approval. The Quality Compliance Manager shall develop and
    implement procedures and systems to ensure Shockwave Medical, Inc. complies with applicable
    regulatory standards such as:

    • ISO 13485 – Medical Devices – Quality Management Systems
    • 21 CFR 820 Quality System Regulation and 21 CFR 803 Medical Device Reporting
    • 2017/745 EU MDR – European Medical Device Regulation (EU MDR)
    • Medical Device Single Audit Program
    • Council of the European Communities Directive 93/42/EEC – Medical Device Directive
    • Australia Therapeutic Goods (Medical Devices) Regulations 2002
    • Canadian Medical Device Regulations (SOR/98-282)
    • Current Good Manufacturing Practices (CGMP) Quality Systems Regulation
    • Other Regulatory and Industry Standards

    Essential Job Functions

    • Responsible for direct supervision of Quality Compliance Specialists
    • Ensure Quality Management System procedures are established and maintained in compliance to International, National and Local regulatory requirements.
    • Identify changes to relevant regulatory requirements and industry standards
    • Administer and manage the Standards Gap Assessment log
    • Undertake gap assessment activities to newer regulatory requirements
    • Work cross functionally to address the identified system gaps and implement changes
    • Train the organization to ensure the new requirements are communicated internally
    • Provide QA support for International Product Registration
    • Ensure regulatory compliance to US, Europe and other International regulations to ensure market access and support commercialization efforts
    • Compile Quality records to support international regulatory submissions
    • Manage the CAPA System
    • Maintain compliance of the CAPA system per relevant procedures
    • Schedule CAPA Board meetings periodically to facilitate review of ongoing CAPAs
    • Coordinate with CAPA owners to ensure assigned action items are completed in an accurate and timely manner
    • Manage the NCR, Servicing, Deviation and Reworks System
    • Administer and manage the NCR/Servicing/Deviations/Rework logs and maintain overall compliance to relevant procedures
    • Work cross-functionally with other teams to track and manage
    • NCR/Servicing/Deviations/Rework activities from initiation through closure
    • Lead the Material Review Board meetings
    • Manage the Audit System
    • Maintain compliance to the Quality Audit procedure
    • Serve as subject matter expert for Quality Management System and Compliance related activities during internal and external audits
    • Administer and manage the audit findings to address audit non-conformances
    • Manage the Supplier Control System
    • Manage and administer the Supplier Files in compliance to internal procedures
    • Ensure Supplier Audits and Supplier Corrective Actions are completed in a timely and accurate manner
    • Oversee scheduling and coordination of Periodic Reviews
    • Schedule Management Review and other periodic reviews
    • Coordinate with cross functional team members to collect relevant data and compile presentation for the reviews
    • Monitor and trend QMS process (CAPA, NCR, Audits, Supplier performance etc.) metrics
    • Identify and drive Quality Management System continuous improvement activities
    • Other relevant duties as assigned

    Requirements

    • BS degree in a related discipline
    • 10+ years’ experience in medical device quality systems and compliance role including a minimum of 2 years of managerial experience
    • Strong understanding of FDA and other International medical device regulations
    • Excellent written and verbal communication skills
    • Experience in supporting International Regulatory Submissions
    • Strong front room audit experience with an ability to effectively present and defend quality systems under your responsibility and management
    • Proficiency in using Statistics, data compilation, analysis, presentation is preferred
    • Project Management experience and excellent organizational skills is preferred
    • RAPS RA certification is preferred
    • Remains current with regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings
    • Responsible for coaching, training and development of subordinates
    • Identifies and manages continuous improvement projects
    • Ability to work in a fast-paced environment while managing multiple priorities
    • Operate as a team and/or independently while demonstrating flexibility to changing requirements


« Back To All Positions