Sr Quality Systems Manager - Risk Management & Standard Compliance
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor’s Degree with 7+ years of relevant experience with 5+ years of managerial experience, OR Master’s degree with 5+ years of relevant experience with 5+ years of managerial experience.
- Direct experience in risk management activities per ISO 14971
- Experience in compliance with medical safety standards such as ISO 60601 and associated particular and collateral standards
- Experience as a key participant in compliance audits by regulatory bodies
Nice to Have
- Leadership experience in the planning, execution and closure of field corrective actions in the medical device industry
- Strong knowledge of medical device regulations and quality standards, including 21 CFR Part 820, ISO 13485, and EU MDR
- Experience in communicating directly with global regulatory bodies
- Experience in leading technical projects
- Influence management skills with a demonstrated ability to work constructively across all functions of an organization
- Experience and participation in medical device industry collaborations, such as standards working groups, industry consortiums or associations
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.
May require domestic and international travel, up to 10% of the time
