Sr QA Engineer, CAPA

Foundation Medicine-posted 2 months ago
Boston, MA
Professional, Scientific, and Technical Services
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The Sr QA Engineer (CAPA) plays a critical role in maintaining and improving Foundation Medicine's quality systems. The role conducts day to day administration of the CAPA process, coordinating the review, documentation and retention of quality records. The Sr QA Engineer, CAPA exercises considerable latitude to prioritize daily activities in a fast-paced environment, monitoring for timely completion of tasks and escalating any potential risks to ensure timely completion of CAPA deliverables. The position coordinates a variety of related tasks, assuming different activities when priorities change and interacting with all departments within FMI to support the effectiveness of the CAPA Quality System. Regular onsite work at a designated FMI location is an essential function of this role. The Sr QA Engineer (CAPA) is an experienced professional with wide-ranging skillsets to assist and support with the CAPA System at FMI. The role will report to the Quality Assurance CAPA manager and will conduct day to day administration of the CAPA process, coordinate the review, documentation and retention of quality records. The Sr QA Engineer, CAPA will exercise considerable latitude to prioritize daily activities in a fast-paced environment, monitor for timely completion of tasks and escalate any potential risks to ensure timely completion of CAPA deliverables. The desired candidate is able to coordinate a variety of related tasks, assume different activities when priorities change and interact with all departments within FMI to support the effectiveness of the CAPA Quality System.

  • Develop and maintain an effective corrective and preventive action program.
  • Monitor CAPA phases and associated due dates to ensure timely progression and closure.
  • Facilitate cross-functional root cause analysis using tools like 5 Whys, Fishbone, and FMEA.
  • Provide technical writing guidance and ensure documentation is compliant with GxP, FDA, CLIA, CAP, ISO 13485, and other applicable standards.
  • Facilitate the CAPA Review Board (CRB), including preparation of materials, coordination of meetings, and documentation of decisions.
  • Monitor CAPA effectiveness and ensure timely follow-up.
  • Support audits and inspections by providing CAPA-related documentation and responses.
  • Collaborate with stakeholders in Operations, R D, Regulatory Affairs, and Clinical teams.
  • Identify trends and systemic issues through data analysis and recommend process improvements.
  • Assist with reporting Key Performance Indictors (KPIs).
  • Other duties as assigned.
  • Bachelor of Science degree or equivalent years of experience in technical or engineering discipline.
  • 3+ years of experience in CAPA management within a regulated environment (biotech, pharma, or diagnostics).
  • 5+ years of related professional experience.
  • 5+ years of Quality Assurance experience; preferably in the medical device or pharmaceutical industry with CAPA management experience.
  • Strong understanding of quality systems and regulatory requirements (GxP, IVD, FDA, ISO, CLIA, CAP).
  • Proficiency in quality tools and methodologies (e.g., 8D, DMAIC, Six Sigma).
  • Excellent communication, documentation, and project management skills.
  • Experience with electronic quality management systems (eQMS).
  • Understanding of HIPAA and importance of privacy of patient data.
  • Commitment to FMI values: integrity, courage, and passion.
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