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**Careers that Change Lives**
A career at Medtronic offers a unique opportunity to be part of a dynamic and innovative organization committed to alleviating pain, restoring health, and extending life for millions of people worldwide.
**Our Mission**
We strive to drive healthcare forward by fostering a culture of excellence, integrity, and collaboration. Our team is dedicated to making sure that every patient receives the best product when they need it.
**Job Description**
The Quality Systems Specialist will play a critical role in developing and maintaining quality programs, including Document Control, Corrective and Preventive Action, Supplier & Distributor Management, and Manage Compliance. This position will provide expertise and guidance in interpreting policies, regulatory, and governmental regulations to ensure compliance.
**Key Responsibilities**
- Develops and maintains quality programs, systems, processes, and procedures to ensure compliance with policies and established internal and external standards and guidelines.
- Provides oversight for the implementation and development of Quality Management Systems Processes to support Medtronic's Global Region.
- Ensures compliance with policies and that the performance of Quality Services conforms to established internal/external standards and guidelines.
**Requirements**
To be successful in this role, you will need:
- Bachelor's degree required, preferably in Engineering, Quality, or equivalent.
- Minimum of 2+ years of relevant experience in Quality System Specialist role or must be knowledgeable with QMS Processes (Document Control, Corrective and Preventive Action, Supplier & Distributor Management, Manage Compliance).
- Excellent communication skills, fluent in English and Spanish (writing & speaking - B2+).
- Knowledge of MS Office, Excel, and computer systems.
- Previous experience leading programs and projects for quality functional groups.
- Quality management or document control experience.
- Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to quality and compliance processes or programs Team player.
- Knowledge of FDA and Regulations.
- Audit - Quality and Compliance experience.
- Corrective and Preventative Action (CAPA).
- Technical Writing experience.
**Nice to Have**
Strong typing skills and ability to write business documents.
