Senior CAPA Specialist: Quality & Compliance Leader

MED Medtronic Inc; Fridley (MN); On-site; USD 94,000 - 140,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

Life Insurance

401(k) with match

Paid Time Off

Job summary

Medtronic is seeking a Senior CAPA Specialist to lead corrective and preventive action activities across Rice Creek and Plymouth Cheshire facilities, ensuring quality system effectiveness and regulatory compliance. This onsite role requires strong investigations, root-cause analysis, and cross-functional collaboration to drive timely improvements.

The ideal candidate has a background in quality, manufacturing, engineering, or life sciences within regulated settings and experience with CAPA

Qualifications

• Bachelor's degree with 4+ years of experience OR Master's degree with 2+ years of experience in Quality, Manufacturing, Engineering, Life Sciences, or a related regulated environment.
• Experience managing CAPA processes within a regulated industry.
• Experience conducting root cause investigations and developing corrective action plans.
• Experience interpreting and applying quality system requirements, procedures, and regulatory standards.
• Experience working cross-functionally to drive issue resolution and process improvements.
• Experience within pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• Experience supporting regulatory inspections and internal or external audits.

Responsibilities

• Lead CAPA activities from initiation through effectiveness verification and closure.
• Review investigations, root cause analyses, and corrective action plans for quality system compliance and effectiveness.
• Provide guidance on quality system requirements, regulatory expectations, and CAPA best practices.
• Partner with manufacturing and functional teams to identify process improvements and drive sustainable corrective actions.
• Monitor CAPA metrics, trends, and reporting to identify compliance risks and improvement opportunities.
• Support internal audits, regulatory inspections, and audit readiness activities, including response development and closure of observations.
• Prepare, review, and maintain quality records, reports, and documentation in accordance with established procedures.
• Mentor team members and provide support for projects related to quality system performance and compliance.

Skills

CAPA management

Root cause analysis

Quality systems

Cross-functional collaboration

Regulatory inspections

Data analysis

Project leadership

Education

Bachelor's degree in Quality/Engineering/Life Sciences

Master's degree in related field

Tools

TrackWise

Job description

Medtronic is seeking a Senior CAPA Specialist to lead corrective and preventive action activities across Rice Creek and Plymouth Cheshire facilities, ensuring quality system effectiveness and regulatory compliance. This onsite role requires strong investigations, root-cause analysis, and cross-functional collaboration to drive timely improvements.

The ideal candidate has a background in quality, manufacturing, engineering, or life sciences within regulated settings and experience with CAPA