CAPA COORDINATOR / FACILITATOR @ STARK PHARMA
Join a leading medical device manufacturer as a CAPA Coordinator / Facilitator for a 12-month engagement. In this high-impact position, you will drive CAPA activities tied specifically to FDA audit findings, focusing on quality excellence and cross-functional collaboration. You will be responsible for leading activities from initiation to closure, including driving root cause analysis using methodologies like 5 Whys and Fishbone diagrams. Possible work locations for this role include Minnesota and California. The pay rate for this position is $50/hr (W2).
As a facilitator, you will lead discussions, ensure team accountability, and coach others on CAPA best practices and compliance. You will partner closely with Quality, Engineering, and Operations teams to improve processes, tools, and reporting. Candidates should have over 5 years of experience in the Medical Device industry and a proactive, solution-driven mindset. Experience with process monitoring and production-related CAPAs is highly desirable for success in this quality-driven engineering environment.
As a facilitator, you will lead discussions, ensure team accountability, and coach others on CAPA best practices and compliance. You will partner closely with Quality, Engineering, and Operations teams to improve processes, tools, and reporting. Candidates should have over 5 years of experience in the Medical Device industry and a proactive, solution-driven mindset. Experience with process monitoring and production-related CAPAs is highly desirable for success in this quality-driven engineering environment.
Key Requirements
Minimum of 5 years experience in the Medical Device industry.
Proven track record in CAPA coordination and coaching teams.
Expertise in Root Cause Analysis methodologies such as 5 Whys and Fishbone.
Strong background in Quality Engineering or a related technical field.
Ability to lead CAPA activities from initial discovery to final closure.
Proficiency in facilitating cross-functional discussions and driving accountability.
Experience working with FDA audit findings and compliance standards.
Ability to partner effectively with Quality, Engineering, and Operations teams.
Skills in improving CAPA processes, tools, and documentation reporting.
Experience with process monitoring and production-related CAPAs is preferred.