The CAPA Manager will be responsible for leading and continuously improving the Corrective and Preventive Action (CAPA) program within a regulated medical device environment. This role owns the CAPA process governance framework, provides oversight of CAPA execution, drives timely resolution of quality issues, facilitates robust investigations and root cause analysis, and partners with cross-functional teams to prevent recurrence of nonconformances. The CAPA Manager ensures CAPAs are effectively managed from initiation through verification of effectiveness while fostering accountability, continuous improvement, and patient-focused quality.
How you will make an impact: - Own and maintain the CAPA process governance framework; establish governance, metrics, escalation pathways, performance standards, review boards, and prioritization based on risk, regulatory impact, patient safety, and business needs.
- Oversee Quality Systems CAPAs end-to-end from initiation through investigation, risk assessment, action planning, implementation, verification of effectiveness, disciplined tracking, and closure.
- Coach and lead teams in structured problem-solving and RCA tools; review investigations to ensure root causes are evidence-based, distinguished from symptoms, and addressed through systemic corrective actions.
- Ensure compliance with applicable FDA QSR/QMSR (21 CFR 820) requirements, ISO 13485, EU MDR, MDSAP expectations, global regulatory requirements, and internal quality procedures related to CAPA.
- Develop and maintain CAPA dashboards, analyze performance trends, communicate CAPA performance and escalation needs, and drive measurable improvements in timeliness, recurrence reduction, closure quality, and effectiveness verification.
- Partner with cross-functional stakeholders to build accountability, gain buy-in for systemic corrective actions, facilitate alignment, and drive prevention-focused quality improvements.
- Lead and develop quality analysts, quality engineers, or CAPA coordinators as applicable; provide coaching on quality systems, investigations, regulatory expectations, and talent development.
- Serves as the site-wide or large-scope CAPA owner, collaborating cross-functionally to facilitate alignment and drive actions that impact multiple teams.
- Other incidental duties assigned by Leadership
What you'll need (Required Qualifications): - Bachelor's degree with six (6) years of relevant experience; or equivalent work experience based on Edwards criteria
- Proven experience leading, owning, and driving Corrective and Preventive Actions (CAPAs) within a regulated industry environment.
- Experience working within highly regulated industries such as medical devices, pharmaceuticals, biotechnology, aerospace, automotive, semiconductor, or other regulated manufacturing environments.
What else we look for (Preferred Qualifications):
- Engineering of Scientific degree
- Medical Device industry experience
- Demonstrated experience serving as a CAPA process owner, governance lead, or quality systems subject matter expert.
- Experience developing and managing CAPA governance frameworks, including performance metrics, review boards, escalation processes, and effectiveness verification programs.
- Experience driving enterprise-wide quality system improvements that resulted in measurable improvements in compliance, CAPA timeliness, recurrence reduction, or overall quality system effectiveness.
- Strong knowledge of quality management systems, root cause analysis methodologies, and structured problem-solving techniques.
- Experience conducting and reviewing investigations, identifying systemic root causes, and implementing sustainable corrective actions.
- Experience utilizing quality metrics and data analysis to drive process improvements and operational effectiveness.
- Experience developing quality dashboards, trend analyses, and executive-level performance reporting.
- Knowledge of risk management methodologies and their application within CAPA investigations and corrective action planning.
- Strong project management experience leading complex, cross-functional initiatives involving Quality, Manufacturing, Regulatory Affairs, Engineering, and Operations stakeholders.
- Lean, Six Sigma, or other continuous improvement certification and demonstrated application of continuous improvement tools.
- Demonstrated ability to lead teams, mentor stakeholders, and drive continuous improvement initiatives.
- Experience leading, coaching, or developing Quality Engineers, Quality Analysts, CAPA Coordinators, or other quality professionals.
- ASQ certification such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.
- Experience working within medical device quality systems governed by FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, EU MDR, and/or MDSAP requirements.
