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Sr Compliance/Audit Specialist (Minneapolis or Memphis - HYBRID: Office/Work from Home)

Memphis, TN 38111
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Sr Compliance/Audit Specialist (Minneapolis or Memphis - HYBRID: Office/Work from Home)


Minneapolis, Minnesota, United States

Requisition #:


Post Date:

Feb 09, 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 **Sr Compliance/Audit Specialist** you will have responsibility foraudit support, complaint handling, medical device reporting, and investigation of complaints for Neuroscience products in accordance with applicable internal procedures and work instructions, and external requirements (regulations or guidance from all regulatory bodies).

The Sr. Compliance/Audit Specialist is an individual contributor with the ability to manage projects and work with other stakeholders to achieve results. This role may act as a mentor or assist with work allocation for team members to meet daily and monthly goals, as well as support problem solving activities to drive continuous improvement and promote an engaged culture.

**A Day in the Life**

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

+ Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects.

+ Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Provides analysis that is in-depth and often provides recommendations on process improvement.

+ May provide guidance, coaching and training to other employees within job area.

+ Ensures work instructions and procedures follow all applicable FDA regulations, specifically 21 CFR Parts 820 and 803.

+ Maintains regulatory, process and product knowledge to provide internal and external audit support, including front room and back-room participation.

+ Prioritizes and leads/participates in the assessment and solution development for identified issues of moderate to high scope and complexity including CAPAs, non-conformances, and quality assurance action plans.

+ Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.

+ Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.

+ Promotes a culture of inclusion, innovation, and engagement, including colleague recognition when appropriate.

**Must Have: Minimum Requirements**

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

Bachelorsdegree with 4+ years of work experience in Quality or regulated industry OR Advanced degree with 2+years of work experience in Quality or regulated industry

**Nice to Have**

+ Complaint handling experience in the Medtronic Customer Quality organization

+ Bachelor of Science degree (includes but not limited to nursing, engineering, science, health care)

+ Ability to work independently or in a team setting

+ Ability to work well under pressure with a positive enthusiastic attitude

+ Strong attention to detail

+ Excellent communication skills (oral and written), with strong organizational and analytical skills

+ Knowledge of basic anatomy, physiology, and medical terminology

+ Knowledge of Tissue and Pharma Regulations

+ Knowledge of:

+ 21CFR, Section 820, Quality System Regulation

+ 21CFR Section 803, Medical Device Reporting

+ 21 CFR 1271

+ EU Directive 2007/47/EC

+ ISO 13485, Quality Systems, Quality Management Systems

+ Knowledge of or experience with problem-solving and process-improvement methodologies (DMAIC)

+ Complaint handling experience or customer service/technical support experience (0-2 years)

+ High level of computer proficiency (e.g. Microsoft Office, SAP, etc)

**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.


Posted: 2022-03-08 Expires: 2022-06-06
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Sr Compliance/Audit Specialist (Minneapolis or Memphis - HYBRID: Office/Work from Home)

Memphis, TN 38111

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