Principal Quality Systems Specialist
Company: Medtronic GmbH
Posted on: February 23, 2021
Written in 1960, our Mission dictates that our first and
foremost priority is to contribute to human welfare. Over a
half-century later, the Mission continues to serve as our ethical
framework and inspirational goal for our employees around the
world.-- In this exciting role as a Principal Quality Systems
Specialist you will have responsibility for leading the CAPA
process, QMS Harmonization, and Audit support activities for the
Medtronic Neurovascular business. A Day in the Life
Responsibilities may include the following and other duties may be
- 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
- 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 company's
- 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. Bachelor's--degree
with 7+ years of work experience in Quality or regulated industry
OR Advanced degree with 5+--years of work experience in Quality 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
- Understanding of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA,
TGA, Health Canada, EU, China & Japan regulations; ISO 13485,
- Knowledge of effective root cause investigation, corrective and
preventive action planning, execution and verification of
effectiveness techniques. Experience with quality tools and process
- Influence management skills; ability to work constructively
across all functions of the organization and build relationships as
well as with external customers and regulators.
- Independent compliance decision maker (based on knowledge of
regulations, available relevant information, alternatives,
- Experience reviewing technical documentation.
- Strong written and verbal communication skills
- Strong critical thinking and analytical skills
- Lean Sigma certified or demonstrated problem solving
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. Let's 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. This employer participates
in the federal E-Verify program to confirm the identity and
employment authorization of all newly hired employees. For further
information about the E-Verify program, please click here .
Keywords: Medtronic GmbH, Irvine , Principal Quality Systems Specialist, Other , Irvine, California
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