CAPA Facilitator

Lead and facilitate the Corrective and Preventive Action (CAPA) process from issue identification through to closure, ensuring quality and timely completion of actions.

Support CAPA Owners by coordinating cross-functional resources, scheduling meetings, and presenting CAPAs during audits and review board meetings.

Mentor teams on root cause analysis, quality problem solving, statistical data analysis, and application of quality tools to resolve complex issues.

Bachelor's or Master's degree in Engineering, Statistics, Quality Management, or a related field (advanced degree is an advantage).

8-10 years of experience in quality roles within the Medtech industry.

Knowledge of global regulations and standards such as 21 CFR Parts 803, 806, 820; ISO 13485; ISO 14971.

Experience with statistical methods, quality and problem-solving tools (8D, DMAIC, SPC, FMEA, Control Plan, LEAN), and facilitation/coaching of teams in manufacturing, R&D, and engineering environments.

Experienced in managing and facilitating CAPA processes in complex, regulated medical technology environments involving cross-functional teams.

Strong capability in applying advanced statistical and quality tools to analyze data, identify root causes, and drive corrective actions.

Proven communication and leadership skills to coach teams and influence stakeholders in a matrix organization.