CAPA Manager

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.