Director of Quality


San Francisco

Work type:


Business sector:

Manufacturing, Transport & Logistics


USD150000.00 - USD200000 per annum

Job reference:


Start date:


Contact email:


Dean Bagnall

Job Purpose:
The role of the position will be to develop, implement and improve the QMS, ensuring that it complies with 21 CFR Part 820, ISO 13485 as well as other applicable international quality standards for the medical device industry. This position serves as a Quality Representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, and company quality goals and priorities. The position will work with key stakeholders to provide leadership and vision, as well as drive alignment towards our quality objectives.

  • Responsible for implementation, maintenance and improvements to the Quality Management System and reporting on performance of QMS to the Leadership Team and dissemination throughout the organization. 
  • Responsible for coordinating and managing all aspects of external quality system audits, including FDA, ISO 13485, notified bodies and other external agencies.
  • Supports R&D initiatives by providing Design Assurance support through all phases of the product development process, with specific focus on risk management.
  • Implements and maintains the CAPA system to meet 21CFR820, ISO 13485, 93/42/EEC and internal requirements. This includes leading CAPA Board meetings, maintaining and presenting metrics to the Leadership team, etc. 
  • As Management Representative, responsible for preparing and conducting quality performance measurements including developing, tracking, and publishing metrics, ensuring company awareness of regulatory and customer requirements and preparing for and presenting to the leadership team on the performance of the quality system. 
  • Implements and maintains Supplier Management process in accordance with 21CRF820, ISO 13485, 93/42/EEC
  • Supervise Quality team comprising of 2-3 direct and other indirect reports.
  • B.S. in Science, Engineering or equivalent combination of education and experience
  • Minimum 10+ years' experience in medical device industry with increasing responsibility
  • 5+ years' experience managing employees
  • Experience in managing the following standards:  21CFR820, ISO 13485, ISO 14971, MDR 2017/745, 93/42/EEC - Medical Device Directive, ISO 10993, ISO 62304, ISO 60601, ISO 62366
  • ISO 13485 Lead Auditor Certification and/or ASQ Quality Auditor
  • Demonstrated  ability to work with international health authorities
  • Experience working in a start-up environment

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