1+ months

Quality Systems Specialist

Medtronic
North Haven, CT 06473
Quality Systems Specialist

Location:

North Haven, Connecticut, United States

Requisition #:

19000MW2

Post Date:

Dec 04, 2019


**Careers that Change Lives**


You will join a team of
mechanical, electrical and software engineers responsible for developing
Medtronics Robotic Assisted Surgery platform through commercial launch and
production scale-up.


**Impactpatient outcomes.Come for a job, stay for a career**


The
Minimally Invasive Therapies Group strives to enable earlier diagnosis, better
treatment, faster complication-free recovery, and enhanced patient outcomes
through less invasive surgical solutions.


SURGICAL
INNOVATIONS set the standard for Minimally Invasive Surgery (MIS) by creating
innovative surgical products and services that focus on obesity and diseases
and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic
region, and the head and neck.


**A Dayin the Life**


This Quality Systems Specialist is
within the Quality Assurance department based in the North Haven, CT area and
reports to the Quality leader in Boston. Responsibilities include product
lifecycle management, training system management, and general Quality Systems
support.


**You will:**


+ Have overall responsibility for supporting theadequacy of Quality System for a Minimally Invasive Surgical System, includingdocumentation and other supporting quality evidence.Process change orders and workflows withinProduct Lifecycle Management SystemAdminister Learning Management SystemGenerate and publish Quality System metricsProvide 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.Provide expertise and guidance in interpretingpolicies, regulatory and/or governmental regulations, and internal regulationsto assure compliance.Work directly with operating entities toprovide process analyses oversight on a continuing basis to enforcerequirements and meet regulations.Lead audit and inspection preparation,resolution of audit and inspection findings and liaises with auditing groupsand inspectors through all stages of the audits.Prepare reports and/or necessary documentation(ex: Corrective and Preventative Actions) and provides to applicablestakeholders, both internal and external.Co-ordinate legal requests in support ofgovernment investigations or litigations.Ensure the quality assurance programs and policiesare maintained and modified regularly.Facilitate uniform standards worldwide andenables best practice sharing, thereby fostering the achievement of company'smission globally.May contribute to the streamlining andcontinuous improvement of the Quality System processes to ensure robust andefficient development and launch of new and innovative products.

+ Interact and form constructive workingrelationships with all levels of leadership within Quality, Regulatory, TestEngineering, Procurement, Marketing, RD, and Operations.

+ Utilize facilitation skills with programshareholders to ensure proper project management, expectation setting, and bestpractices are utilized.


**Must haves: Minimum requirements** :


A Bachelors Degree and 2 years of relevant experience.


**Nice to haves:**


+ Two years experience in Medical Device Industry inclusive of:Quality Systems, Document Control, and /or Training Administration.

+ Good communication skills, both written and oral in English and must be computer literate.

+ Experience in a regulated Medical Device work environment

+ Skills/Qualifications:

+ Experience with Agile Product Lifecycle Management (PLM) System

+ Experience with Cornerstone Learning Management Systems (LMS)

+ Experience working with Surgical Robotics systems

+ Knowledge of or experience in developing and manufacturing medical devices in conformance with Quality System Regulations including but not limited to ISO 13485 and FDA 21 CFR Part 820 requirements.

+ Knowledge of analytical tools and methods related to design, development and manufacturing.

+ Experience in a development manufacturing environment, including:


+ Processing documentation, change orders, and workflows

+ Maintaining Design History File (DHF) Device Master Record (DMR)


+ Skills/Qualifications: Proficient in Microsoft Office tools, including:Word, Excel, PowerPoint


**Working Conditions:**


+ Office environment where the employee would be standing and sitting most of the day at a desk or in a conference room for meetings.

+ Candidate may be asked to travel periodically (10% annually) to support the project(s) (~once or twice a year).


**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 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.


**EEO**


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: http://www.uscis.gov/e-verify/employees .
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.

Categories

Posted: 2019-12-06 Expires: 2020-02-13

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Quality Systems Specialist

Medtronic
North Haven, CT 06473

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