Role: Quality Compliance Analyst


Reports to: Manager of Quality Systems

Job Description:

The Quality Compliance Analyst will be the primary contact for all post market surveillance activities, the lead of the CAPA program, and the corrections & removals program. They will be responsible for monitoring and managing complaint processing and adverse event determination, CAPA management, corrections & removals process development, and metrics reporting. This includes working cross-functionally to investigate product malfunctions, product design and/or labeling questions, as well as customer dissatisfaction issues, and the regular monitoring and reporting of complaint handling status. They will monitor metrics and drive process improvements based on performance trends. This individual will contribute to complaint handling, and correction & removals process requirements, including updating SOPs and Work Instructions to ensure compliance with domestic regulations such as 21 CFR Part 802.198 & 803 & 806 and build process to be compliant with evolving global regulations and standards such as the EU-MDD/MDR and ISO13485: 2016. The incumbent for this position will support additional activities as assigned. 


Key Performance Elements/Essential Functions:

  • Responsible for processing complaints & facilitating investigation throughout the complaint lifecycle to ensure proper documentation and timely closure
  • Leads Complaint Assessment Board to perform review potentially reportable complaints per Medical Device Regulations
  • Responsible for working with Regulatory Affairs to ensure on time reporting of MDRs
  • Leads CAPA Review Board to facilitate closure of open CAPAs, and review CAPA extensions and escalations
  • Establishes Quality Data Metrics related to Complaints, CAPAs and other QMS processes
  • Serve as a backroom subject matter expert (SME) for complaint processing, complaint investigation, MDR determinations, and CAPAs during audits
  • Collaborates internally to develop & manage the corrections and removals process including appropriate feeders and tie in with other processes (design controls, complaints, CAPA, production, etc.)
  • Organize and analyze data highlighting trends in preparation for Management Review meeting
  • Offers new ideas and continually drives quality system improvement Performs all other duties as assigned


  • B.S. in Engineering, Sciences, S.T.E.M. or similar/equivalent preferred
  • Minimum of 10 years of experience in medical device industry required
  • Advanced knowledge of Medical Device Complaint files and quality record documentation
  • Advanced knowledge of Quality Management System and Regulatory reporting requirements for Medical Devices (21 CFR Part 820.198 and 803 requirements, EU MDD/MDR requirements)
  • Previous complaint handling experience with radiation therapy equipment preferred
  • Previous experience with corrections & removals (21 CFR 806) preferred
  • Ability to work effectively in a collaborative and dynamic environment
  • Leadership and interpersonal skills to develop and manage good working relationships with internal departments (quality, operations, engineering, medical affairs, clinical, and regulatory); strong written and verbal communication skills


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