1+ months

Sr Quality Systems Specialist

Fridley, MN 55432
Sr Quality Systems Specialist


Fridley, Minnesota, United States

Requisition #:


Post Date:

Jun 19, 2020

**Careers that ChangeLives**

**The RestorativeTherapies Group** develops life-restoring
therapies and healthcare solutions that span the care continuum; integrating
technologies and applying clinical and economic evidence to increase patient
access, improve efficiency of procedures and deliver successful patient
outcomes. There are four divisions within RTG: Brain Therapies,
Pain Therapies, Specialty Therapies and Spine.

**A Day in the Life**

In this exciting role as
a Sr. Quality Systems Specialist, you will have responsibility for partnering
with the organization in the execution of Nonconformance (NC) and CAPA
activities to ensure the CAPA program is efficient, effective and
compliant. You will apply knowledge and experience to ensure compliance
to our NC and Corrective Action and Preventative Action (CAPA) processes and
Medical Device regulations and requirements. In addition, work to improve
the CAPA program including CAPA processes, enterprise software systems,
reporting of metrics and trends and training programs.

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

+ As CAPA team member, support awide portfolio of NCs and CAPAs to ensure process compliance, appropriaterigor and timely execution including, but not limited to:

+ Evaluation of CAPAinvestigations, action execution, effectiveness determination, associateddecisions and CAPA documentation.

+ Support NC and CAPA teams inunderstanding the processes, best practices, record content, and softwaretools.

+ Development of robust qualityNC and CAPA files and records.

+ Provide continuous improvementand rigorous assessment of CAPA activities and documentation to assurecompliance with Neuromodulation CAPA processes, FDA regulations, ISO13485, and Medical Device Requirements through the review of CAPA recordsat critical phases.

+ Support and mentor NC and CAPAOwners in planning and executing the processes, best practices, recordcontent, and software tools.

+ Support the development andimplementation of Quality System NC and CAPA procedures, software, andtraining programs.

+ Support external and internalaudits and inspections for NC and CAPA records and processes.

+ Provide expert guidance ininterpreting governmental regulations, agency guidelines and Medtronicinternal policies in general and specific to CAPA to assure compliance.

+ Understand all Neuro qualitypolicy/system interfaces and dependencies to NC and CAPA processes andbest practices.

+ Complete other NC, CAPA andquality related functions and projects as assigned.

**Must Have: MinimumRequirements**

Bachelor'sdegree 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**

+ Knowledge of FDA regulations(21 CFR 820), ISO 13485

+ Degree in Science orEngineering

+ Experience in the medicaldevice or pharmaceuticals industry

+ Experience working withnon-conformances, and corrective action and preventive action processes

+ Experience with quality toolsand process improvement techniques

+ Strong critical thinking andanalytical skills

+ Knowledge of effective rootcause investigation, corrective and preventive action planning andexecution and verification of effectiveness techniques

+ Lean Sigma certified ordemonstrated problem solving experience

+ Independent compliance decisionmaker (based on knowledge of regulations, available relevant information,alternatives, risk)

+ Influence management skills;ability to work constructively across all functions of the organizationand build relationships

+ Strong technical writing anddocumentation review skills


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.

**PhysicalJob Requirements**

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: 2020-06-23 Expires: 2020-08-30

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Sr Quality Systems Specialist

Fridley, MN 55432

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