Senior Quality Systems Specialist - CAPA & Recall

Manage day-to-day administration of the CAPA process Coordinate CAPA activities from initiation through closure Lead CAPA review meetings and track action item completion Coordinate investigations, root cause analyses, corrective and preventive actions, and effectiveness verification Develop CAPA metrics and trend analysis reports for Quality Management Reviews Coordinate product recalls, advisory notices, field actions, and other post-market actions Initiate, process, and drive Health Hazard Evaluation activities to completion Organize and lead the Device Safety Review Board Assist with recall strategies, risk assessments, customer notifications, and effectiveness checks Track field action progress and required activities Support regulatory reporting and documentation for recalls and advisory notices Conduct continuous improvement initiatives throughout the Quality Management System Support training related to CAPA, recalls, advisory notices, and quality system processes Provide front-room support and records for internal audits, external audits, MDSAP audits, and regulatory inspections Assist with audit responses and corrective action implementation Provide back-up support for complaint intake and complaint investigations Report to the VP of Operations, Customer Service & QARA Lead cross-functional teams during CAPA investigations, recalls, advisory notices, and field actions Requirements Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related technical discipline preferred Equivalent combination of education and relevant experience may be considered Minimum 5 to 8 years of experience in Quality Assurance, Quality Systems, Regulatory Affairs, or related roles within the medical device industry or another regulated industry Experience managing CAPAs, nonconformances, recalls, advisory notices, field actions, complaints, or quality system processes preferred Experience participating in regulatory inspections and quality audits preferred Working knowledge of CAPA methodologies, root cause analysis tools, and effectiveness verification techniques Strong understanding of Quality Management System requirements Knowledge of FDA 21 CFR Part 820,

ISO 13485

, MDSAP, EU MDR, Canadian Medical Device Regulations, and other applicable global medical device regulations Strong organizational and project management skills Excellent written and verbal communication skills Ability to manage multiple projects and priorities simultaneously Strong analytical and problem-solving skills Ability to effectively collaborate with cross-functional teams Proficiency in Microsoft Office applications and quality management software systems Ability to interpret procedures, regulations, technical documentation, and quality records No relocation offered; ideal candidate currently resides in the Greater Twin Cities metropolitan area Core Competencies Demonstrates expertise in managing the CAPA process, including investigations, root cause analyses, and corrective actions within the medical device industry. Proficient in regulatory compliance, quality management systems, and leading cross-functional teams to ensure effective product recalls and quality assurance. Highest-signal resume keywords CAPA Management Quality Management System Expertise Regulatory Compliance Knowledge Root Cause Analysis ATS Optimization Keywords Hard Skills CAPA Methodologies Root Cause Analysis Tools Effectiveness Verification Techniques Quality System Processes Regulatory Inspection Participation Quality Audits FDA 21 CFR Part 820 ISO 13485

MDSAP

EU MDR

Soft Skills Strong Organizational Skills Excellent Communication Skills Analytical Problem-Solving Skills Collaboration Skills Ability to Manage Multiple Projects Industry Keywords Medical Device Industry Quality Assurance Regulatory Affairs Field Actions Advisory Notices Tools & Technologies Microsoft Office Applications Quality Management Software Systems #J-18808-Ljbffr Jobtailor