Sr. Quality Systems Specialist- CAPA & Recall
$110,000–$115,000 year
HybridChaska, Minnesota, United States
Job Summary
Manage day-to-day administration of the CAPA process from initiation through closure, leading review meetings and tracking action item completion. Coordinate product recalls, advisory notices, and field actions while developing metrics and trend analysis reports for Quality Management Reviews. Partner with cross-functional stakeholders to facilitate investigations, root cause analyses, and effectiveness verifications in compliance with FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements. Provide front-room support for internal and external audits, assist with audit responses, and drive continuous improvement initiatives throughout the Quality Management System. Lead the Device Safety Review Board and support training activities related to quality system processes.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related technical discipline
- Minimum 5 to 8 years of experience in Quality Assurance, Quality Systems, Regulatory Affairs, or related roles within the medical device industry or other regulated industry
- 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
- Knowledge of: ISO 13485
- Knowledge of: MDSAP
- Knowledge of: EU MDR
- Knowledge of: Canadian Medical Device Regulations
- Knowledge of: 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
- Must be able to work on-site at Chaska, MN headquarters three days a week
- Must currently reside in the Greater Twin Cities metropolitan area
Desired Qualifications
- 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
- Experience managing CAPAs, nonconformances, recalls, advisory notices, field actions, complaints, or quality system processes preferred
- Experience participating in regulatory inspections and quality audits preferred
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