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QMS Specialist CAPA-Coach & Reviewer
The CAPA Coach is a skilled quality professional responsible for the independent review, evaluation, and disposition of Corrective and Preventive Actions (CAPAs) within the organization's Quality Management System (QMS). This role serves as a critical quality control checkpoint within the CAPA Workstream, ensuring that all CAPAs are complete, compliant, and effective.
The ideal candidate will bring solid hands-on experience in quality systems within a regulated medical device environment, with a thorough understanding of CAPA methodologies, root cause analysis, and regulatory requirements. This individual will review CAPAs at various stages of the lifecycle, from initial submission through effectiveness verification and formal closure, ensuring alignment with 21 CFR 820, ISO 13485, and other applicable global standards.
The successful candidate will be a detail-oriented individual contributor capable of working collaboratively across teams while independently managing review responsibilities with minimal supervision.
Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
· Open CAPA Review
o Perform structured reviews of newly initiated and in-progress CAPAs to assess completeness, accuracy, and alignment with regulatory requirements before advancement to the next phase.
o Evaluate adequacy of problem statements, scope definitions, initial containment actions, and risk assessments.
o Review root cause analysis (RCA) submissions, including 5-Why, Fishbone/Ishikawa, Fault Tree Analysis, and similar methodologies, to confirm rigor, traceability, and adequacy.
o Assess proposed corrective and preventive action plans for proportionality to identified risk and root cause and verify that actions are measurable and time-bound.
o Identify deficiencies in open CAPA packages and return them to CAPA owners with documented rationale and specific remediation guidance.
o Verify proper linkage between CAPAs and associated source records, including deviations, nonconformances, customer complaints, audit findings, and management review outputs.
o Monitor open CAPA aging and escalate overdue or stalled CAPAs to the QMS Sub-System Lead – CAPA in accordance with SOP timelines.
o Track and document review decisions and feedback within the electronic QMS (eQMS) to maintain a complete and auditable record.
· Closed CAPA Review & Effectiveness Verification
o Conduct thorough reviews of closed CAPAs, evaluating whether implemented actions have adequately resolved the identified nonconformance and prevented recurrence.
o Review closure evidence packages, including updated SOPs, training records, validation data, re-inspection results, and trend data, against pre-defined acceptance criteria.
o Verify that all action items within the CAPA plan have been completed, documented, and appropriately signed off.
o Assess whether preventive actions have been applied to applicable processes, products, or sites beyond the original scope of the CAPA.
o Review to ensure CAPAs comply with applicable regulatory standards, including 21 CFR Part 820 (), ISO 13485:2016, and other applicable global quality standards.
· Coaching
o CAPA Coaches are responsible for evaluating CAPAs to industry standards and regulatory requirements and actively transferring CAPA knowledge, skills, and best practices to Full-Time Employees (FTEs) to build sustainable internal capability across the organization.
· Regulatory Compliance & Documentation
o Ensure all reviewed CAPAs comply with applicable regulatory standards, including 21 CFR Part 820 (), ISO 13485:2016, and other applicable global quality standards.
o Maintain accurate, complete, and retrievable CAPA review records to support internal audits, regulatory inspections (FDA, Notified Body), and customer quality audits.
o Support preparation of CAPA status summaries, trending reports, and presentations for Management Review and remediation program governance meetings.
o Participate in inspection-readiness activities by ensuring CAPA documentation meets agency expectations for completeness and traceability.
· Metrics, Reporting & Continuous Improvement
o Contribute data and observations to dashboards, metrics, and reporting tools used to monitor CAPA Workstream progress and effectiveness.
o Identify trends and recurring deficiency types across reviewed CAPAs to inform systemic process improvement recommendations.
o Provide input on improvements to CAPA templates, review checklists, and work instructions to strengthen review consistency and efficiency.
o Support identification of systemic risks within the CAPA process and collaborate with the Sub-System Lead to prioritize continuous improvement actions.
· Collaboration & Communication
o Collaborate with CAPA owners, facilitators, remediation leads, and cross-functional teams across multiple sites to support timely and complete CAPA resolution.
o Communicate review findings, deficiencies, and approval decisions clearly and constructively to CAPA owners and QA leadership.
o Serve as a resource for CAPA owners seeking guidance on RCA methodology, documentation requirements, and effectiveness check design.
o Participate in CAPA-related meetings, workstream reviews, and cross-functional improvement sessions as required.
Pay: $33.38 - $40.20 per hour
Work Location: Remote
