Senior Quality Systems CAPA Specialist
Medtronic
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.
As a CAPA Specialist at Medtronic’s Warsaw, IN manufacturing site, you will be integral to ensuring the quality and safety of our spinal implant and brain/ENT instrument components. You will lead investigations into product and process nonconformances, customer complaints, and audit findings specific to the design, manufacturing, and distribution of these critical medical devices. In collaboration with cross-functional teams, you will facilitate root cause analysis and drive the development of effective corrective and preventive actions to support both regulatory compliance and Medtronic’s mission of improving patient outcomes.
You will be responsible for tracking, documenting, and managing CAPA records within the Quality Management System (QMS), ensuring all CAPA activities meet internal standards and FDA/ISO regulatory requirements. The CAPA Specialist will monitor the implementation and effectiveness of CAPA actions, prepare metrics and reports for management review and regulatory inspections, and act as a subject matter expert during internal and external audits. You will also identify and support continuous improvement opportunities in CAPA processes, and train site staff on CAPA procedures and best practices, helping to foster a culture of quality at Warsaw.
Your work will have a direct impact on the reliability and safety of Medtronic’s spinal implants and brain/ENT instrument components, supporting our commitment to alleviating pain, restoring health, and extending life.
This role is 100% onsite at our Warsaw, IN manufacturing site.
Responsibilities may include the following and other duties may be assigned.
Lead investigations for product and process nonconformances, complaints, and audit findings.
Facilitate root cause analysis and work with cross-functional teams to determine effective corrective and preventive actions.
Track, document, and manage CAPA records in the Quality Management System (QMS).
Monitor the implementation and effectiveness of CAPA actions.
Prepare CAPA metrics and reports for management review and regulatory inspections.
Participate in internal and external audits as a CAPA subject matter expert.
Identify and support continuous improvement opportunities in CAPA processes.
Train staff on CAPA procedures and best practices.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor's degree with 4+ years of work experience in Quality or regulated industry OR Advanced degree with 2+ years of work experience in Quality or regulated industry
Nice to Have
Experience working with non‐conformances, corrective and preventive actions.
Experience conducting effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
Support CAPA process and several individual records for a specific set of CAPAs that will have high visibility and require increased oversight.
Experience in medical device, pharmaceutical and/or a comparable regulated environment.
Physical Job Requirements
The 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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A 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.
This 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 plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It 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.