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Senior Quality System Manager - NM - Rice Creek/Fridley, MN; Onsite
Job in
Minneapolis, Anoka County, Minnesota, 55432, USA
Listed on 2026-07-15
Listing for:
Medtronic Inc.
Full Time
position Listed on 2026-07-15
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Job Description & How to Apply Below
Location: Minneapolis
We anticipate the application window for this opening will close on - 18 Jul 2026
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission-to alleviate pain, restore health, and extend life-we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most.
Our Neuromodulation Operating Unit provides advanced therapies for chronic pain, movement disorders, and other neurological conditions. Through spinal cord stimulation, deep brain stimulation, and targeted drug delivery systems, we deliver personalized treatments that restore function, reduce symptoms, and improve quality of life worldwide.
Check us out on Linked In:
Medtronic Brain Modulation and Pain Interventions
A Day in the Life
The Senior Quality Systems Manager provides strategic leadership for the Quality Management System (QMS), ensuring its effectiveness, regulatory compliance, and continuous improvement. This role is accountable for overseeing the Corrective and Preventive Action (CAPA) program and key quality system processes, including quality planning, management review, quality metrics, training, change control, and enterprise quality initiatives. By driving governance, cross-functional collaboration, and operational excellence, the Senior Quality Systems Manager ensures timely issue resolution, effective quality system performance, and alignment with business and regulatory requirements.
Responsibilities may include the following and other duties may be assigned.
* Provide strategic and operational leadership for the Quality Management System (QMS) and continuous improvement initiatives.
* Lead the governance and oversight of the CAPA program, ensuring timely execution, effectiveness, and regulatory compliance.
* Oversee core quality system processes, including change control, training, management review, quality planning, and quality metrics.
* Monitor quality system performance, identify trends, and drive improvements through data-driven decision making.
* Partner cross-functionally to ensure quality system processes support business objectives while meeting applicable regulatory and quality requirements.
* Establish and maintain effective governance for quality system changes and enterprise quality initiatives.
* Support internal and external audits, regulatory inspections, and remediation activities as needed.
* Foster a culture of quality, accountability, and continuous improvement across the organization.
Location:
Rice Creek East/Fridley, MN (Onsite)
Onsite:
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We're working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects.
Must Have (Minimum Requirements)
To be considered for this role, please ensure the minimum requirements are evident on your resume.
* Bachelor's degree required with a minimum of 7 years in Quality Systems within the medical device industry with 5+ years of people management experience.
* OR advance degree with a minimum of 5 years in Quality Systems within the medical device industry with 5+ years of people management experience.
Nice to Have (Preferred Qualifications)
* Strong understanding of global regulatory requirements for medical devices, including FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation.
* Excellent written and verbal communication skills, with the ability to influence stakeholders and communicate effectively across all levels of the organization.
* Demonstrated experience managing or leading CAPA processes in a regulated environment, including issue assessment, investigation, root cause analysis, action planning, implementation, and effectiveness verification.
* Demonstrated leadership capability, including coaching others, driving cross-functional collaboration, and fostering a culture of quality and continuous improvement.
* Strong understanding of quality systems, including change control, nonconformance management, risk management and management review.
* Strong analytical and problem-solving skills, with experience using structured methodologies to support fact-based…
Position Requirements
10+ Years
work experience
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