Senior Program Manager Quality
Medtronic is looking for a Senior Program Manager Quality
The general responsibility is to provide Quality leadership for the Vitatron business in Maastricht. Serve as the Management Representative for Vitatron. This position is the key laison for the business with regulatory agencies, customers and with other Vitatron and Medtronic functions. Engage in strategic planning and execution for the business representing the voice of Quality. Maintain a relationship with key suppliers within the CRHF business following the quality agreements between businesses.A Day in the Life
As the Management Representative of the Vitatron business this position is responsible for all Quality functional duties. This includes all interfaces with notified bodies/regulatory agencies for internal audits and requests for information. Provide the Vitatron Quality leadership for requests, forums, councils and requests from any Medtronic entity. Managing internal audits from corporate or CVG groups. Growing the Vitatron business involves customer contact within Marketing campaigns as well as representing the business when customers request Quality information or dialogue. Provide field support when Quality issues impact our products. Participate in strategic planning for the business providing key Quality inputs as well as owning objectives identified in Vitatron strategy.
- Demonstrated knowledge of quality systems and regulations while being in a Quality role
- Working knowledge of ISO/AIMDD
- Experience leading audits and/or interfacing with notified bodies during audits
- Experience in a medical device business
- 5+ years of engineering experience
- Bachelor’s degree in engineering or science
- Strong written and verbal communication skills
- Strong competencies in judgement and problem solving (especially root cause analysis)
- Working knowledge of multiple quality disciplines, especially reliability, safety and compliance
- Experience with FDA part 820 regulations
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.