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1+ months

Sr Quality Systems Specialist

Medtronic
Irvine, CA 92604
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Sr Quality Systems Specialist

Location:

Irvine, California, United States

Requisition #:

21000MPO

Post Date:

Oct 18, 2021


**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 **Sr** **Quality Systems Specialist** you will have responsibility forsupporting the CAPA process, change control, and internal/external audit support activities for the Medtronic Neurovascular business.


**A Day in the Life**


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


+ Provides input to 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 feedback 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.

+ Supports 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.

+ 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.

+ Travel requirement:less than 25%


**Must Have: Minimum Requirements**


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


Bachelors Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.


**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)
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: 2022-03-25 Expires: 2022-05-27
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Sr Quality Systems Specialist

Medtronic
Irvine, CA 92604

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