Sr Quality Systems Manager - Document Control

Medtronic   •  

Northridge, CA

Industry: Manufacturing

  •  

8 - 10 years

Posted 33 days ago

Careers That Change Lives


In this exciting role as a Sr. Quality Systems Manager for Document Control you will have responsibility for 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 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.

A Day in the Life

  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that 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 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.
  • Prepares 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.
  • Facilitates 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 Change Control, Configuration Management, and Records centers.

  • Experience leading CAPA and continuous improvement projects using DMAIC

  • 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


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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