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Sr Quality Systems Specialist - Northridge, CA or Remote within the US

Medtronic
Northridge, CA 91325 Work Remotely
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Sr Quality Systems Specialist - Northridge, CA or Remote within the US

Location:

Northridge, California, United States

Requisition #:

2200042U

Post Date:

Feb 25, 2022


**Careers That Change Lives**


A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.


In this exciting role as a SeniorQuality Systems Specialist, you will have responsibility for supporting the CAPA process, change control, and internal/external audit support activities for the Medtronic Diabetes business.


**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.


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.


+ 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 companys mission globally.


**Must Have: Minimum Requirements**


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


Bachelors Degree with 4+ years of work experience in Quality and/or regulated industry OR Advanced degree with 2+ years of work experience in Quality and/or regulated industry


**Nice to Have**


+ Degree in Science or Engineering

+ Experience working with CAPA, Management Review, Change Control and Audit processes.

+ Experience with TrackWise and Agile PLM software

+ Basic understanding of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China Japan regulations; ISO 13485, MDSAP, etc.

+ Functional knowledge of effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques. Experience with quality tools and process improvement techniques.

+ Experience reviewing technical documentation.

+ Strong written and verbal communication skills

+ Strong critical thinking and analytical skills


**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. Lets 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 requirement:less than 25%
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.

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Posted: 2022-03-08 Expires: 2022-06-06
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Sr Quality Systems Specialist - Northridge, CA or Remote within the US

Medtronic
Northridge, CA 91325

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