CAPA - Facilitator

Description:

Responsibilities,

Coach and guide CAPA owners and teams on how to address all deliverables of the CAPA process effectively and efficiently, ensures only CAPA's which meet quality standards are approved. Maintain CAPA timeliness KPIs

CAPA Owner, facilitator and extensive knowledge of root cause analysis

5 + years in CAPA management within a medical device or regulated environment

Background in CAPA processing and completion

Practical knowledge of standards and regulations pertaining to the relevant QMS (21 CFR 820, ISO 13485, etc.)

Investigation / problem solving skills

Understanding of Trackwise"

Good to have

Knowledge and experience in key QMS disciplines (production and process quality control…)

Coaching skills

Basic project management skills