Senior CAPA Specialist - Minneapolis, MN
$93.6k - $140.4kMedtronic Inc
Senior CAPA Specialist position supporting two pharmaceutical manufacturing facilities in Minnesota. Leads corrective and preventive action activities within the quality management system, partnering with manufacturing and operational teams to ensure regulatory compliance and drive continuous improvement across both sites.
Responsibilities
- Lead CAPA activities from initiation through effectiveness verification and closure
- Review investigations, root cause analyses, and corrective action plans for compliance and effectiveness
- Partner with manufacturing and functional teams to identify improvements and drive sustainable corrective actions
- Monitor CAPA metrics and trends to identify compliance risks and improvement opportunities
- Support internal audits, regulatory inspections, and audit readiness activities
Requirements
- Bachelor's degree with 4+ years experience in Quality, Manufacturing, Engineering, Life Sciences, or regulated environment
- Master's degree with 2+ years experience in Quality, Manufacturing, Engineering, Life Sciences, or regulated environment
- Experience managing Corrective and Preventive Action processes in regulated industry
- Root cause investigation and corrective action plan development experience
- Knowledge of quality system requirements, procedures, and regulatory standards
- Experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments
Vacancy posted 4 days ago
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