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Principal Quality Applications Specialist at Medtronic

Posted in General Business 30+ days ago.

Type: Full-Time
Location: northridge, California





Job Description:


Careers that Change Lives

In this exciting role as a Principal Quality Applications Specialist you will have responsibility for conducting a compliant validation process for quality system software which requires formal validation documentation.

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.

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

Responsibilities may include the following and other duties may be assigned.

  • Taking a leadership role as a part of the quality team responsible for Computer Systems Validation (CSV) and ensure projects are being executed as per Quality System Regulations, and GxPs.


  • Provides expert-level coaching and mentoring to the organization regarding CSV standards, regulations, guidance, and best practices


  • Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.


  • Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.


  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.


  • Reports on the status of validation activities to fulfill regulatory requirements.


  • Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.


  • Performs system administration and configuration of quality information technology systems.

    Must Have: Minimum Requirements


    Bachelor's Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced Degree Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality.


    Nice to Have



    • Project Management experience and/or certification
    • Experience in Medical Device/FDA Regulated Industry


    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)


    Additional Information



    • Posting Date: Nov 20, 2020
    • Travel: No






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