Senior Quality Systems Specialist – CAPA & Recall

IMRIS

Senior CAPA and Recall Specialist coordinating corrective actions, recalls, and audits. Supporting IMRIS, a global intraoperative MRI and surgical-environment company, in regulatory compliance and QMS improvement.

Posted 8/15/2026full-timeChaska • Minnesota • 🇺🇸 United StatesSenior💰 $110,000 - $115,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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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 ManagementQuality Management System ExpertiseRegulatory Compliance KnowledgeRoot Cause AnalysisProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CAPA MethodologiesRoot Cause Analysis ToolsEffectiveness Verification TechniquesQuality System ProcessesRegulatory Inspection ParticipationQuality AuditsFDA 21 CFR Part 820ISO 13485MDSAPEU MDR

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsAnalytical Problem-Solving SkillsCollaboration SkillsAbility to Manage Multiple Projects

Tools & Technologies

Microsoft Office ApplicationsQuality Management Software Systems

Industry Keywords

Medical Device IndustryQuality AssuranceRegulatory AffairsField ActionsAdvisory Notices

About the role

Key responsibilities & impact

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

What you’ll need

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

Benefits

Comp & perks

Health Insurance
Dental Insurance
401(k) savings plus matching
Flexible Spending Account
Life Insurance
Disability Insurance
Vision Insurance
Generous PTO
Incentive bonus
Paid Parental Leave