🌎
This job posting isn't available in all website languages
📁
Quality
📅
190007C3 Requisition #
Careers That Change Lives
 
Impact patient outcomes.  Come for a job, stay for a career.

Medtronic Care Management Services (MCMS) is a leader in remote patient monitoring and telehealth. We help healthcare providers and patients stay connected outside of routine clinical and acute medical visits by enabling patients to send timely and objective personal health data from the comfort of their home, helping healthcare providers identify early risk indicators and intervene as needed. MCMS is at the vanguard of remote patient monitoring and telehealth, with a long track-record of delivering results through partnerships with health systems, payers, and post-acute care providers.


A Day in the Life

In this exciting role as the Quality System Specialist, you will have responsibility for the Medical Device Quality management system. You will provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality requirements conform to established internal and external standards and guidelines.

 
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits, including the performance of internal audit activities.
  • Defines metrics and prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Ensures the quality assurance programs and policies are implemented, maintained and modified regularly. Including new implementations.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Defines performance indicators based upon leadership expectations and monitors actual results.
  • Assist with the release of the quarterly QMR content to top management.
  • Work across the MCMS to ensure quality objectives are being met.
  • Oversees and/or prepares reports for top management on operations quality status, costs and product performance.
  • Maintains active participation in both industry and professional associations having legitimate relationships to quality matters.
  • Act as deputy for the Site Quality Manager as required.
Must Have: Minimum Qualifications
  • Bachelor's degree with 2+ years of quality experience in medical devices 
Nice to Have
  • ISO 13485 and FDA 21 CFR 820 quality system requirements
  • Master's Degree
  • Proficiency in statistical, quality and continuous improvement methods and tools
  • Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) certificate
  • Proficiency in statistical, quality and continuous improvement methods and tools
  • Ability to communicate with co-workers, suppliers, external customers and healthcare professionals in a clear, concise, professional, knowledgeable, and friendly manner
  • Knowledge of medical terminology, physiology and/or applicable disease states, therapies and technologies
  • Project management skills
  • Excellent verbal communication skills
  • Strong technical writing experience
  • Ability to effectively manage multiple projects and priorities
  • Ability to work with Microsoft Office applications
 
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.

 
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.

 
EEO

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

 

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions
Please try again.

Oops!

Either there was a problem on our end with the action you just performed, or we are currently having technical difficulties with our system. Please try again later.

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Learn More

Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

Learn More

Regulatory

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Learn More

Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

Learn More

EMPLOYEE STORY:
ENGINEERING

Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

Learn More

WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.

Learn More

We value what
makes you
unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

Learn More
The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.