Director of Quality Assurance

Quality Assurance San Francisco, California


Description

Spire Health is seeking an experienced Director of Quality Assurance professional to lead Spire’s Quality Department. This individual will be responsible for ensuring Spire’s Quality Management System is established, implemented, and maintained in accordance with relevant regulatory standards and established procedures. This position will implement, foster, and lead a culture of Total Quality Management that supports current business priorities and enables the company's future growth. 

Responsibilities:

  • Recruit, develop, and manage the Quality Assurance team as the company's pipeline and development activities expand
  • Ensure that the Quality Management System is established, implemented, and maintained in compliance with all relevant regulatory standards
  • Ensure that the Quality Management System supports current business priorities and improve upon it to enable and support company growth
  • Report and communicate to Executive Management on the performance of the quality management system and any needed improvements or quality issues
  • Measure, track, and report on quality objectives
  • Resolve any deficiencies in the Quality Management System and implement a culture of continual improvement
  • Define priorities, delegate responsibilities and plan quality assurance operations
  • Represent quality in product development efforts and ensure compliance with premarket and post-market activities as per regulations and Quality Management System
  • Manage a comprehensive internal auditing program and ensure that internal audits are performed no less than annually by an independent source
  • Manage third party audits including regulatory inspections and audits
  • Prepare responses and corrective actions to external/internal audits as necessary
  • Manage and monitor the corrective and preventative action programs and customer complaint system
  • Manage and maintain all quality records such as documents, proficiency data, external audits, reports, training records, corrective action reports, change control, internal audits, complaints, etc.
  • Handle the maintenance and control of the Quality Management System Manual (QSM) and all internally controlled documents; review and revise the QSM and internal procedures on an annual basis, and ensure that the QSM contents comply with all relevant regulatory standards
  • Train personnel on the Quality Management System and relevant regulatory requirements, both upon initial hire and on an on-going basis
  • Maintain Training Matrix and personnel training files, and ensure all employees have documented training that is commensurate with job responsibilities; review training files annually
  • Approve external providers and maintain the Approved Supplier List; perform audits on critical external providers, when necessary
  • Serve as subject matter expert on quality initiatives for both internal and external purposes
  • Maintain an awareness of internal and external market conditions that impact the delivery of services and products, adjusting as necessary
  • Work with Operations and other departments to ensure adequate systems are implemented to ensure product quality and regulatory compliance
  • Participate in operational and strategic discussions that impact the entire organization
  • Develop and maintain overall quality plan to achieve quality objectives
  • Support quality planning and quality assurance activities related to new product development and post-market product maintenance
  • Establish and maintain effective cross-functional team communications to advance quality
  • Manage quality assurance activities with strategic partners
  • Support regulatory team with premarket regulatory activities including submissions
Requirements:
  • BS degree in Mathematics, Business, Computer Science, Engineering or equivalent
  • 10+ years’ experience in medical device Quality Assurance
  • Experience with medical devices containing software or Software as a Medical Device required
  • Must have 5+ years’ experience in managing and leading QA teams
  • Served as Management Representative
  • Experience in key QMS areas including design controls, complaint handling, CAPA, supplier controls, internal audits, risk management and post-market surveillance
  • Experience implementing and maintaining of QMS as per ISO 13485
  • Experience or practical knowledge of ISO 14971, IEC 62304, IEC 62366 and cybersecurity standards
  • Experience with FDA 510(k) process, CE marking, and other regulatory submissions a plus
  • Excellent verbal and written communications skills. Must be able to communicate effectively at all levels of interaction
  • Experience with various medical device development / lifecycle models including Agile
  • Demonstrated ability to translate regulations or regulatory guidance into internal policies, procedures, and work instructions
  • Experience with electronics QMS
  • Ability to work both independently and as part of a highly integrated team
  • Comfortable working in a fast-paced and agile environment
Spire Health also provides additional benefits and is an Equal Opportunity Employer (M/F/V/D).