MDCP (Medical Device Combination Product) CAPA Coordinator
Responsible for the facilitation of site Medical Device Corrective Action and Preventive Action (CAPA) governance processes in compliance with US FDA 21 CFR 820 regulatory requirements and other applicable device regulations. This role leads the management and administration of the Device CAPA Review Board (CRB).
Work with cross-functional teams to coordinate required activities of CAPAs (e.g., CAPA Evaluations, root cause analysis, Investigation Action Plans, Risk Assessments, Health Hazard Evaluation documents, etc.), and ensure CAPA records are documented appropriately.
Assist with monitoring and coordination the different quality sub-system feeders to the CAPA process such as Complaint Handling, Nonconformance Materials processes, Risk Management, Management Review, Internal Audits, etc.
Continuously track CAPA actions and upcoming due dates to ensure timely completion.
Monitor and report on metrics on the CAPA system.
Represent CAPAs during audits, Management Review, and CAPA Review Board meetings.
Continuously drive process improvements for the CAPA system.
Assist with CAPA training program, including training for root cause analysis and technical writing.
Monitor and enforce department compliance with Pfizer policies and procedures.
Provides coaching to site technical experts on the problem-solving process and review technical content.
Develop and assist in the execution of corrective/preventative action plans as needed.
Interface with individual CAPA Record owners to coach and facilitate progression through CAPA process.
Verify that all procedural CAPA requirements are met. Periodically audit site CAPA files to ensure the files are complete and audit-ready and contain all required objective evidence etc.
Support the Site Device CAPA manager as needed and escalate identified resource constraints in a timely manner to management.
Responsible for the facilitation, coordination, and scheduling of periodic site device/combination products CAPA Review Board (CRB)
Prepare CAPA section of the Annual Product Record Review
May support CAPA Investigations as needed.
Bachelor’s degree in Mechanical, Chemical, Packaging, Biomedical or related Engineering Science is required. Advanced degree desirable.
2-5 years of experience in a Device CAPA role
Demonstrated device CAPA knowledge and experience with US FDA 21 CFR 820.100 CAPA requirements.
Must be detail-oriented with expert knowledge of root cause analysis and key CAPA regulatory requirements (e.g. US, EU and other key geographies)
ASQ CQE (American Society for Quality Certified Quality Engineer)
Sitting for extended periods of time
Lifting may be required (items under 20lbs)
Perform data analysis/metrics collection
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Primarily a day-shift role
May require some evenings and weekends to support cross site meetings as well as priority project deadlines
OTHER JOB DETAILS:
Last day to apply: 8//2021
Employee Referral Bonus eligible