Senior Quality Systems Specialist
MedtronicAbout the role
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
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 Sr Quality Systems Specialist- CAPA 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.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We work a minimum of five days per week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities may include the following and other duties may be assigned.
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.
Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
Provides Corrective and Preventive CAPA oversite and guidance.
Develops employee communication and training programs that focus on the elements of a companywide CAPA and compliance program.
Required Knowledge and Experience:
Requires a Bachelor's degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
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
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