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Senior Quality Assurance Manager

Company: X4 Life Sciences
Location: San Francisco
Posted on: January 16, 2022

Job Description:

This role is primarily to support clients in the San Francisco Bay Area and a growing list of national and international clients.
OverviewThe Quality Manager's goal is multi-faceted. The first goal is to be a strong strategic and tactical quality leader for their client and teams in charge of implementing and maintaining a Quality System and associated compliance activities for the design, development, and manufacturing of medical devices in compliance with applicable quality and regulatory requirements, including FDA, FDB, EU, MDR, IVDR, MDSAP, ISO 13485, ISO 14971, ISO 62366, ISO 62304 and other applicable standards. Second, they will be direct client delivery lead of 7-10 clients and oversee their direct client team as well as an "apprentice" lead supporting 5-7 additional clients. Third, they are a mentor and teacher supporting the development of fellow team members along their growth path.
JOB RESPONSIBILITIES:

  • Authorize and serve as Management Representative as defined by the FDA QSR and ISO 13485 to represent client companies during compliance audits
  • Manage and modify comprehensive quality systems to support the development and contract manufacturing of medical products of various Clients and product Classes
  • Ensure compliance with the applicable US and international regulatory requirements and standards pertaining to quality
  • Develop and monitor quality system processes, including CAPA, change control, design control, complaint investigations, supplier oversight, internal audit, nonconforming materials
  • Provide quality input for product development, manufacturing, and external suppliers as they relate to the companies' solutions and products
  • Recruit and develop Quality staff to achieve organizational objectives and meet client project needs; Coach and mentor staff.
  • Assess potential gaps in both internal and client quality systems, identify improvements and implement to achieve compliance
    EXPERIENCE REQUIREMENTS:
    • 5+ years of experience in the Medical device industry involving product development and manufacturing
    • In-depth knowledge of FDA 820, FDA 801/803/806/807/809/812/830, FDB, MDD, ISO 13485, ISO 14971
    • Familiar with MDR, QSR, IEC 62304, IEC 60601, IEC 62366, ISO 10993, 11607, 62366, 11135, 11137, 11138
    • 3-5 years of quality assurance and quality managerial experience

Keywords: X4 Life Sciences, San Francisco , Senior Quality Assurance Manager, Executive , San Francisco, California

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