We anticipate the application window for this opening will close on - 22 May 2025

 

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.

In this exciting role as a Quality Systems Specialist – CAPA Specialist supporting the Tempe Campus - you will have responsibility for compliance to the Corrective and Preventive Action (CAPA) processes and Medical Device regulations and requirements, serve as a CAPA subject matter expert; provide guidance to CAPA owners and CAPA Board members to develop CAPA activities and conduct assessment of CAPA documentation.

The Quality System CAPA Specialist will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements by rigorously assessing CAPA activities and documentation. They will participate in CAPA Board activities, provide guidance and mentorship on CAPA processes and tools, and report on CAPA metrics. Additionally, they will support the development and implementation of CAPA procedures, software, and training, and assist in internal and external audits and inspections.

Responsibilities may include the following and other duties may be assigned.

• Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

• Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

• Prepare reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.

• Coordinate legal requests in support of government investigations or litigations.

• Ensure the quality assurance programs and policies are maintained and modified regularly.

• Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

• Location: Onsite - Tempe, AZ.

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 2+ years of work experience in Quality or regulated industry OR Advanced degree with 0 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.

• Experience working with non‐conformances, corrective and preventive actions.

• Strong analytical, process improvement, critical thinking and decision-making skills.

• Ability to educate people in the CAPA program.

• CAPA documentation systems experience (e.g. TrackWise Digital Quality Management Software).

• Lean Six Sigma certification (Yellow belt, Green belt, or Black belt).

• Influence management skills; ability to work constructively across all functions of the organization as well as external customers.

• Project management skills.

• Experience reviewing technical documentation.

• Strong written and verbal communication skills.

• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and