Senior CAPA Specialist - Minneapolis, MN

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

We anticipate the application window for this opening will close on - 12 Oct 2026Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.A Day in the LifeSupporting 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.Primary ResponsibilitiesLead 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.Required QualificationsBachelor'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.Preferred QualificationsExperience 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.For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.U.S. Work Authorization & SponsorshipAt Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail] .Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.Salary ranges for U.S (excl. PR) locations (USD):$93,600.00 - $140,400.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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 , and Simple Steps (global well-being program).The following benefits and additional compensation are available to all regular employees: 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) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.Further details are available at the link below:Medtronic benefits and compensation plansIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.