CAPA Facilitator

CAPA Facilitator (PHIAJP00001859)

Work Location: Bothell Washington USA 98021 / Can be remote, depending on experience

Duration: 6 months contract to start

Description:

Can be remote, depending on experience

CAPA Facilitator, You will support the Corrective and Preventive Action (CAPA) process from issue identification to closure and ensuring adequate execution of process and the quality of CAPA record content.

You are responsible for: Supporting CAPA activities: assessing complex investigations and corrective actions, reviewing test and other complex performance data, leading complex root cause analysis and quality problem solving Facilitate product and process CAPA investigations from issue identification through implementation of solution and effectiveness monitoring Support CAPA Owner in all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines Support CAPA Owners in the presentation of CAPAs during audits and CAPA Review Board meetings Mentor cross functional teams with the implementation of appropriate root cause analysis techniques Mentor the analyze of quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances

To succeed in this role, youll need a customer-first attitude and the following: B.S in Engineering or other relevant academic field as statistics, quality management, etc., advanced degrees an advantage 5+ years experience in quality roles in medical device or other regulated industry Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971 Good understanding of statistical methods, quality tools, problem solving tools and methodologies (i.e. 8D, DMAIC, SPC, FMEA, Control Plan, LEAN) an advantage Experience as team facilitator / team coach Work experience in complex organizations with Manufacturing, R&D and Engineering environments Strong communication and interpersonal skills, ability to coach teams in matrix environment cross-functional teams Strong technical writing skills Ability to resolve complex issues in creative ways and influence stakeholders accordingly Multi-tasking and decision-making capabilities Self-starter, motivated, action-oriented Experience working in global corporate environment Fluent English, Addition of contract CAPA facilitators to help manage incoming CAPAs due to inspection activity.