Sr. Quality Systems Specialist

Medtronic is searching for an experienced Sr. Quality Systems Specialist to join our team and help drive our mission of improving patient outcomes. The ideal candidate will have a combination of technical aptitude, problem solving skills, and strong communication abilities. The Sr. Quality Systems Specialist will be responsible for ensuring our quality systems comply with applicable standards, regulations, and company policies. This will require a close working relationship with multiple departments, including the Quality Assurance, Regulatory, and Manufacturing teams. To be successful in this role, the Sr. Quality Systems Specialist must possess a strong understanding of medical device regulations and industry best practices.The ideal candidate will possess: • A Bachelor’s degree in a relevant scientific field • At least 5 years of experience in a Quality Systems role in the medical device industry • Working knowledge of applicable regulations such as 21CFR820, ISO 13485, and Medical Device Directive • Experience with quality system implementations, software validation, and change control • Excellent communication and organizational skillsIf this sounds like the right opportunity for you, we look forward to hearing from you!

Responsibilities:

1. Ensure quality systems comply with applicable standards, regulations, and company policies.
2. Maintain a close working relationship with multiple departments, including Quality Assurance, Regulatory, and Manufacturing.
3. Possess a strong understanding of medical device regulations and industry best practices.
4. Implement quality systems, software validation, and change control.
5. Communicate effectively and maintain excellent organizational skills.
6. Monitor and review product development processes to ensure compliance with applicable regulations.
7. Investigate and document any quality system issues and non-conformances.
8. Develop and maintain quality system metrics and reports.
9. Provide guidance and training on quality system processes to ensure compliance.
10. Collaborate with other departments and stakeholders to ensure products meet customer requirements.

According to JobzMall, the average salary range for a Sr. Quality Systems Specialist in Minneapolis, MN, USA is between $92,000 and $130,000. This may vary depending on the employer, experience, and qualifications.

Medtronic plc is the world's largest medical device company that generates the majority of its sales and profits from the US healthcare system and is headquartered on the island of Ireland.