Quality System Manager

Quality Assurance San Francisco, California


Description

Spire Health is building the future of remote patient monitoring. We give physicians insights into their patients' health between doctor visits, helping them better manage high-risk chronic disease patients. In particular, we serve patients in the U.S. who have chronic respiratory diseases (COPD, Asthma) with a novel sensor and algorithm system that identifies changes in a patient's health. We focus our efforts on patients identified by their doctor as good candidates for our monitoring program and enroll them at little to no cost to the patient.

Responsibilities:

  • Performs a wide variety of activities to ensure quality system compliance with applicable regulatory requirements.
  • Independently perform internal audit on regular interval to ensure compliance
  • Responsible for Document Control to ensure quality records documentation completeness and availability especially during audit with external regulatory agencies.
  • Participates in cross-functional meetings with internal and external parties as required.
  • Supports management and tracking of quality system records (e.g. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) 
  • Supports management review process through development and generation of quality system metrics, and generate monthly data for those metrics.
  • Works directly with internal clients with assistance from management and/or more senior level investigators to ensure follow-up of quality issues.
  • Manage and coordinate CAPA activities from opening a new CAPA to closure and effectiveness check.
  • Other tasks as assigned by the management

 

Qualifications:

  • 10+ years of Medical Device field 
  • Proficient in ISO13485
    Previous experience in internal and external audits   
  • Thorough understanding of medical device Quality System relationship with FDA-QSR
  • Previous experience in various elements of Quality System such as CAPA, NC, MRB, Documentation Control, Training management, Audit, QMR, etc.