Senior CAPA Specialist - Onsite Quality & Compliance Lead

Medtronic; Minneapolis (MN); On-site; USD 94,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

Medtronic is seeking a Senior CAPA Specialist to lead CAPA activities across the Rice Creek and Plymouth Cheshire facilities. The role requires onsite presence five days a week at Rice Creek in Fridley, Minnesota, with travel between sites.

You will drive investigations, root-cause analyses, and CAPA closure while ensuring regulatory compliance and quality system effectiveness. You will mentor teammates, support audits, and partner with manufacturing to drive sustainable improvements in a highly

Qualifications

• Bachelor's degree with 4+ years of experience in Quality, Manufacturing, Engineering, Life Sciences, or a related regulated environment.
• Experience managing CAPA processes within a regulated industry.
• Experience interpreting quality system requirements and regulatory standards.
• Experience supporting internal audits and regulatory inspections.

Responsibilities

• Lead CAPA activities from initiation through closure and effectiveness verification.
• Review investigations, root cause analyses and corrective action plans.
• Provide guidance on quality system requirements and regulatory expectations.
• Partner with manufacturing and functional teams to drive process improvements.
• Monitor CAPA metrics and reporting to identify risks and opportunities.
• Support audit readiness and response development for observations.

Skills

CAPA management

Root cause analysis

Investigations

Quality systems

Cross-functional collaboration

Regulatory compliance

Audits support

Quality data analysis

TrackWise knowledge

Education

Bachelor's degree

Master's degree

Tools

TrackWise

Quality Management System

Job description

Medtronic is seeking a Senior CAPA Specialist to lead CAPA activities across the Rice Creek and Plymouth Cheshire facilities. The role requires onsite presence five days a week at Rice Creek in Fridley, Minnesota, with travel between sites.

You will drive investigations, root-cause analyses, and CAPA closure while ensuring regulatory compliance and quality system effectiveness. You will mentor teammates, support audits, and partner with manufacturing to drive sustainable improvements in a highly