Senior Capa And Quality Specialist (Usa/Remote)

Careers that Change Lives
Position can be remote in the United States.
Bring your talents to an industry leader in medical technology and healthcare solutions - we're a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.
In this exciting role as a Senior CAPA and Quality Specialist supporting the Enterprise Functional CAPA group - 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.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.

• Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with Medtronic internal policies in general and specific to CAPA process, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations through the review of CAPA records at critical phases.
• Participate in CAPA Board activity and perform CAPA Specialist role. Provide guidance, support and mentorship to CAPA Owners, CAPA Board Members and CAPA Board Chairs regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools.
• Provide CAPA metrics and reporting on critical aspects regarding the health of the CAPA process.
• Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs.
• Support internal and external audits and inspections for CAPA records and processes. Participate in audits and inspections in multiple audit support roles in the front and back room.
• Provides 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.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Must Have: Minimum Requirements

• Bachelor's degree plus 4+ years of relevant quality experience (2+ years with an Advanced Degree).

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, PQM )
• 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 Part 11), ISO 13485, and Medtronic quality requirements

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)
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. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.