- This position is responsible for compliance to the Corrective and Preventative Action (CAPA) process, and to applicable Medical Device and IVD regulations and requirements by serving as a subject matter expert in providing guidance to CAPA owners, and working closely with CAPA Review Board (CRB) members in the administration of CAPA activities and the rigorous assessment of CAPA documentation.
- Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with the CAPA process, FDA regulations, ISO 13485, and Medical Device and IVD requirements through the review of CAPA records at critical phases.
- Provide guidance, support and mentorship to CAPA owners regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools.
- Support CRB and senior leadership with metrics and reporting on critical aspects regarding the health of the CAPA process.
- Participate and coordinate CRB activities and perform CAPA Specialist role throughout the site.
- Support the continuous improvement of CAPA procedures, CAPA software, and CAPA training programs.
- Provide guidance in interpreting governmental regulations, agency guidelines and internal policies in general and specific to CAPA to assure compliance.
- Support internal and external audits and inspections for CAPA records and processes and other roles as needed.
- Perform other related duties as assigned.
- Bachelor's degree and 5+ years or Master's degree with 2+ years in a quality, manufacturing, or leadership role (preferably in managing the CAPA process)
- Experience working with CAPA, complaints, and nonconformances
- Experience in medical device, pharmaceutical, IVD and/or a comparable regulated environment
- Influence management skills; ability to work constructively across all functions of the organization as well as with external customers, notified bodies, regulatory agencies, and competent authorities
- Project management skills
- CAPA documentation systems experience (e.g. CATSWeb, MasterControl, Trackwise,etc.)
- Experience reviewing CAPA, complaint, nonconformance documentation (preferably as an independent reviewer)
- Strong written and verbal communication skills
- Ability to educate people in the CAPA program
- Experience with quality tools and process improvement techniques
- Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
- Strong analytical and decision making skills
- Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and CAPA requirements in general