Quality Systems Specialist
Bachelor’s Degree with 2+ years of experience in a quality role for medical devices and/or pharmaceutical OR Master’s Degree with 0+ years of experience in a quality role for medical devices and/or pharmaceuticals.
Nice to Have
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Bachelor’s or Master’s Degree in Engineering
- Knowledge of FDA regulations (21 Part 820), ISO 13485, and Medtronic quality requirements associated with CAPA.
- Influence management skills; ability to work constructively across all functions of the organization and build relationships.
- Strong technical writing and documentation review skills. Ability to develop and deliver presentations.
- Experience working with non-conformances, and corrective action and preventive action processes.
- Experience with quality tools and process improvement techniques.
- Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk).
- Ability to analyze and interpret data.
- Knowledge of Neuromodulation products, technologies and therapies.
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.