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Quality
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1900040W Requisition #

Job Title: Sr. Quality Systems Manager

Req Number: 1900040W

Location: Northridge CA


Careers That Change Lives


In this exciting role as a Sr. Quality Systems Manager you will have responsibility for Quality Systems Improvements, Change Control, Configuration Management and the Records Center. You will have the opportunity to lead continuous improvement projects to gain efficiencies while maintain compliance in your area of responsibility. You will participate in corporate initiatives to standardize and implement common systems across Medtronic. You will have the opportunity to manage daily document control activities and develop a growing department with talent from multiple backgrounds and expertise.


DIABETES 

Transforming diabetes care together, for greater freedom and better health.


Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers. This role supports our two business units.


ADVANCED INSULIN MANAGEMENT is focused on serving patients in need of insulin pump therapy. The Advanced Insulin Management (AIM) business unit is our history and our heritage and remains focused on driving increased automation to our insulin pump platform, to maximize the time people are within a set target glucose range. The ultimate goal is to develop a fully automated closed loop system.

NON-INTENSIVE DIABETES THERAPIES play a prominent role in our strategy to transform our business into a holistic diabetes management company. As we look to support patients across the disease continuum, it is critical for us to continue expanding our reach to type 2 patients in need of better diagnostic and monitoring solutions to manage their glucose levels.


We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.


Visit www.medtronicdiabetes.com  to see an overview of the products in our Diabetes product portfolio.  

 

A Day in the Life


 

  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies.
  • Ensures the performance and quality of services 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 functions 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.
  • Prepares and presents reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Co-ordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Implements uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company’s mission globally.

 

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

 

  • Bachelor’s degree and minimum of 7 years of experience in quality and/or document controls with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of experience in quality and/or document controls with 5+ years of managerial experience.    

Nice to Have

  • Experience working in Quality Management Systems such as Change Control, and Configuration Management.

  • Experience leading CAPA and continuous improvement projects using DMAIC.

  • Experience doing project management of large scale projects.

  • Deep knowledge and understanding of other areas of the Quality Management System.

  • Knowledge and understanding of Medical Device Regulations such as QSR, JPAL, ISO13485:2016.

  • ASQ Certifications

  
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.

Physical Job Requirements

The physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Travel may be required up to 25%.

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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.

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