CAPA Manager / CAPA Facilitator (Freelance)
Coach and Guide to CAPA Owners and teams on how to address all deliverables of the CAPA Process effectively and efficiently - ensures only CAPAs which meet Quality Standards are approved.
Key Areas of Responsibility
- Works with CAPA Initiators to refine problem description so that they are clear and actionable in the CAPA process, informs them of CRB decision about their Request.
- Support intake process of CAPA Requests from feeder processes to present to the CRB board/Approver per process.
- Maintains CAPA Intake record, ensuring timely escalation into the Trackwise Request per process
- Support CRB Process- may be called upon to present CAPA System Health metrics, prepare presentation decks and/or keep minutes for CRB reviews.
- Act as the center of knowledge for all the CAPA practices and the Trackwise QCM CAPA tool, obtains support when needed from Corporate resources
- Assigns the CAPA Approvers.
- Particiaptes in CAPA Team Kickoffs to share overview of CAPA Deliverables, ensures team understands what criteria for a successful CAPA are, encouraging use of process tools, job aids and best practices.
- Participates in CAPA Team meetings to give advice on tools / approaches to take to address deliverables of CAPA, helps team keep awareness of interfaces with other processes / interfaces and customer and/or auditor viewpoint
- Coach and guide CAPA Owners through the CAPA process.
- Review of CAPA execution / record ? assure CAPA quality standards are met for execution and documentation before the CAPA may proceed to the next key step.
- Escalates concerns first to the CAPA Owner, then if still not addressed- follows appropriate escalation path (ie: CAPA Sponsor, Management Representative)
- Communicates feedback from external reviewers to the CAPA Owner / Team
- Actively engage with CAPA central team, and global CAPA Community of Practice to support continuous improvement efforts in the CAPA process.
Competences & Skills
- Technical degree or equivalent background
- Quality System Audit skills / background
- Coaching skills
- Basic QMS Understanding (ie: what is cfr 820, ISO13485, EUMDR) Knowledge / experience in key QMS disciplines and/or practical knowledge of standards and regulations pertaining the the QMS scope working within (ie: medical device= awareness of ISO-13485, 21 CFR 820, EU Med Device Directive)
- Leading teams / Kaizens
- Problem Solving skills / appropriate selection and use of Root Cause and Process analysis tools such as Ishikawa, 5 Why, PRIDE, Design of Experiments, DMAIC, Fault Tree Analysis, Process Flow Diagramming, SIPOC etc...
- Basic Statistical / Analytical abilities including sampling plan selection, SPC, familiarity with basic hypothesis testing tools
- Strong communication skills- emphasis on technical writing and Medical Device GDP requirements/approaches
- Influential leadership
- Basic project management skills
- Critical Thinking Skills