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Compliance
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19000MTV Requisition #
Careers that Change Lives
 

RTG (Restorative Therapies Group) OVERVIEW

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.  There are four divisions within RTG:  Brain Therapies, Pain Therapies, Specialty Therapies and Spine.

 
A Day in the Life
 

In this exciting role as a Sr. CAPA Specialist, you will have responsibility for partnering with the organization in the execution of Nonconformance (NC) and CAPA activities to ensure the CAPA program is efficient, effective and compliant.  You will apply knowledge and experience to ensure compliance to our NC and Corrective Action and Preventative Action (CAPA) processes and Medical Device regulations and requirements.  In addition, work to improve the CAPA program including CAPA processes, enterprise software systems, reporting of metrics and trends and training programs.

 

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

 
  • As CAPA team member, support a wide portfolio of NCs and CAPAs to ensure process compliance, appropriate rigor and timely execution including, but not limited to:
  • Evaluation of CAPA investigations, action execution, effectiveness determination, associated decisions and CAPA documentation.
  • Support NC and CAPA teams in understanding the processes, best practices, record content, and software tools.
  • Development of robust quality NC and CAPA files and records.
  • Provide continuous improvement and rigorous assessment of CAPA activities and documentation to assure compliance with Neuromodulation CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases.
  • Support and mentor NC and CAPA Owners in planning and executing the processes, best practices, record content, and software tools.
  • Support the development and implementation of Quality System NC and CAPA procedures, software, and training programs.
  • Support external and internal audits and inspections for NC and CAPA records and processes.
  • Provide expert guidance in interpreting governmental regulations, agency guidelines and Medtronic internal policies in general and specific to CAPA to assure compliance.
  • Understand all Neuro quality policy/system interfaces and dependencies to NC and CAPA processes and best practices.
  • Complete other NC, CAPA and quality related functions and projects as assigned.
Must Have: Minimum Requirements
  • Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
 
Nice to Have
  • Knowledge of FDA regulations (21 CFR 820), ISO 13485
  • Degree in Science or Engineering
  • Experience in the medical device or pharmaceuticals industry
  • Experience working with non-conformances, and corrective action and preventive action processes
  • Experience with quality tools and process improvement techniques
  • Strong critical thinking and analytical skills
  • Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
  • Lean Sigma certified or demonstrated problem solving experience
  • Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk)
  • Influence management skills; ability to work constructively across all functions of the organization and build relationships
  • Strong technical writing and documentation review skills

About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)

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Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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