Medtronic
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.
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. In collaboration with cross‑functional teams, you will facilitate root cause analysis and drive the development of effective corrective and preventive actions to support regulatory compliance and improve 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 implementation, 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.
This role is
100 onsite
at our Warsaw, IN manufacturing site.
Responsibilities
Lead investigations for product and process nonconformances, complaints and audit findings.
Facilitate root cause analysis and determine effective corrective and preventive actions in cross‑functional teams.
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
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. Health, dental, vision insurance, Health Savings Account, Flexible Spending Account, Life insurance, long‑term disability leave, dependent daycare spending account, tuition assistance, and global well‑being program are available to regular employees.
Salary ranges for U.S. locations (USD): $89,600.00 – $134,400.00. The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.
About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity. Our mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
Learn more about our business, mission, and our commitment to diversity
here .
EEO Statement 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.
#J-18808-Ljbffr
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. In collaboration with cross‑functional teams, you will facilitate root cause analysis and drive the development of effective corrective and preventive actions to support regulatory compliance and improve 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 implementation, 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.
This role is
100 onsite
at our Warsaw, IN manufacturing site.
Responsibilities
Lead investigations for product and process nonconformances, complaints and audit findings.
Facilitate root cause analysis and determine effective corrective and preventive actions in cross‑functional teams.
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
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. Health, dental, vision insurance, Health Savings Account, Flexible Spending Account, Life insurance, long‑term disability leave, dependent daycare spending account, tuition assistance, and global well‑being program are available to regular employees.
Salary ranges for U.S. locations (USD): $89,600.00 – $134,400.00. The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.
About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity. Our mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
Learn more about our business, mission, and our commitment to diversity
here .
EEO Statement 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.
#J-18808-Ljbffr