Senior CAPA Specialist - Minneapolis, MN

Medtronic•Minneapolis, MN

1d•Onsite

About The Position

Supporting both the Rice Creek and Cheshire Plymouth manufacturing facilities, this role is part of a Quality organization focused on ensuring the safety, quality, and reliability of pharmaceutical products delivered to patients worldwide. The Quality function partners closely with manufacturing, operations, and compliance teams to maintain effective quality systems, drive continuous improvement, and ensure adherence to internal standards and regulatory requirements. This position is based onsite at the Rice Creek facility in Fridley, Minnesota, with responsibility for supporting CAPA portfolios across both Rice Creek and Plymouth Cheshire. Onsite presence is required five (5) days per week to support operations, quality system activities, and cross-functional collaboration. Some travel between sites is expected. The Senior CAPA Specialist leads and maintains Corrective and Preventive Action (CAPA) activities within the Quality Management System for the Rice Creek and Plymouth Cheshire facilities. This role partners with manufacturing, quality, and operational teams to drive timely investigations, effective root cause analysis, documentation, reporting, and closure of quality system records. The position plays a key role in maintaining regulatory compliance, strengthening quality system effectiveness, and advancing continuous improvement initiatives across both sites.

Requirements

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 Corrective and Preventive Action (CAPA) processes within a regulated industry.

Nice To Haves

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.
Knowledge of Quality Management Systems (such as TrackWise) and quality compliance frameworks.
Experience analyzing quality system data and developing compliance or performance metrics.
Project leadership experience with quality or continuous improvement initiatives.

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.

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)