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4 days old

Quality Systems Specialist

Northridge, CA 91325
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Quality Systems Specialist


Northridge, California, United States

Requisition #:


Post Date:

4 days ago

**Careers That ChangeLives**

In this exciting role as a Quality Systems Specialist you
will have responsibility for facilitating the
creation and maintenance of quality policies, procedures and Quality System
metrics. By improving and executing
policies and procedures to ensure processes meet global standards, the Quality
System Specialist keeps Quality System relevant and up to date with internal
and external requirements.

This role resides in the
Diabetes Group Quality Systems Department and serves as liaison to the global
Corporate Quality team. Through this
relationship this person will receive the tools, training and support necessary
to ensure that the practices he/she is following at the local site are in line
with Medtronic Enterprise policies.


Transforming diabetes care together, for greater freedom and better health.

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 at to
see an overview of the products in our Diabetes product portfolio.

**A Day in the Life**

+ You will collect, analyze and publish QualitySystem metrics used in our Quality meetings such as Management Review.

+ You will analyze quality processes foreffectiveness and contribute to continual improvement by driving processimprovements.

+ You will serve as implementation coordinator whennew or changing Enterprise policies are released.

+ You will support improvement efforts as part ofdepartmental and cross-functional quality improvement (QIP) projects.

+ You will support CAPA investigations, correctiveactions and effectiveness checks.

+ You will support all third party and InternalAudits. Provide back room and SME support as needed.

+ You will perform other related duties asassigned.

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

+ Provides oversight for the development andmaintenance of quality programs, systems, processes and procedures that ensurecompliance with policies and that the performance and quality of servicesconform to established internal and external standards and guidelines.

+ Provides expertise and guidance in interpretingpolicies, regulatory and/or governmental regulations, and internal regulationsto assure compliance.

+ Works directly with operating entities toprovide process analyses oversight on a continuing basis to enforcerequirements and meet regulations.

+ Leads audit and inspection preparation,resolution of audit and inspection findings and liaises with auditing groupsand 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 ofgovernment investigations or litigations.

+ Ensures the quality assurance programs andpolicies are maintained and modified regularly.

+ Facilitates uniform standards worldwide andenables best practice sharing, thereby fostering the achievement of company'smission globally.

**Must Have: MinimumRequirements**

**Tobe considered for this role, please ensure the minimum requirements are evidenton your resume.**

Degree with 2+ years of work experience in Quality and/or experience in a
regulated industry OR Advanced Degree Engineering, Science or technical field
with 0+ years of work experience in Quality and/or experience in a regulated

**Nice to Have**

+ Understanding of FDAs Quality System Regulation and ISO13485 requirements for quality management systems, including supportingCAPA investigations or similar activities in other regulated environments.

+ Experience with document control, process improvementand project management, database administration processes, or similaractivities, in a regulated or highly structured environment (e.g., medicaldevice, aerospace, automotive, military)

+ Familiarity with modern ERP systems, PLM systems,manufacturing and Quality System documentation (i.e., parts, BOMs, itemmasters, SOP, WI)

+ Ability to communicate in writing clearly and concisely

+ Highly capable of attention to detail and accuracy

+ Ability to work in a team environment

+ Strong time management, organizational, andprioritization skills

+ Ability to effectively manage multiple projects andpriorities, with a high degree of initiative and good judgment.

+ Ability to interface professionally at all levels of theorganization.

**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 JobRequirements**

The above statements are intended to describe the general
nature and level of work being performed by employees assigned to this
position, but they are not an exhaustive list of all the required
responsibilities and skills of this position.

The physical demands described within the Day in the Life
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.

must be domestic and international up to 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.


Posted: 2020-02-14 Expires: 2020-03-20
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