Software Quality Systems Specialist — CAPA & Audit Readiness

Medtronic; Mounds View (MN); On-site; USD 75,000 - 113,000; Full time

Job summary

Medtronic is seeking a Software Quality Systems Specialist to support software quality system execution for Affera software products within the Cardiac Ablation Solutions unit. This onsite role focuses on CAPAs, field actions, and compliance activities across cross-functional teams to ensure audit readiness and robust documentation.

The candidate will work with Quality, R&D, Regulatory, Medical Safety, and Product Security teams to maintain complete, audit-ready records and drive continuous

Qualifications

• Bachelor's degree with 2+ years in quality systems.
• Experience coordinating multiple deliverables and action items.
• Strong written and verbal communication for controlled documents.
• Ability to interpret procedures and apply quality system requirements.

Responsibilities

• Leads audit and inspection readiness for software quality system areas, including CAPA records and metrics.
• Guides interpretation of policies, regulations, and internal procedures to ensure compliance.
• Supports assessment of regulatory changes for software areas.
• Executes software CAPAs with organized owners and tracking.
• Coordinates field corrective actions for Affera software and tracks status.
• Collaborates with Quality, R&D, Regulatory, Medical Safety, Product Security and Field Quality teams.
• Maintains and tracks KPIs for software quality activities and prepares weekly reports.
• Provides process oversight with cross-functional teams to ensure compliant delivery.
• Assists with closure of audit findings and corrective actions.
• Supports integration and stabilization of software quality systems for larger deployments.
• Identifies opportunities to improve quality system execution and documentation.

Skills

Quality system knowledge

CAPA management

Regulatory compliance

Cross-functional collaboration

Documentation control

Education

Bachelor's degree

Advanced degree

Tools

TrackWise

Jira

Agile PLM

Job description

Medtronic is seeking a Software Quality Systems Specialist to support software quality system execution for Affera software products within the Cardiac Ablation Solutions unit. This onsite role focuses on CAPAs, field actions, and compliance activities across cross-functional teams to ensure audit readiness and robust documentation.

The candidate will work with Quality, R&D, Regulatory, Medical Safety, and Product Security teams to maintain complete, audit-ready records and drive continuous