Sr. Quality Assurance Engineer

Employment Type

: Full-Time

Industry

: Miscellaneous



Sr. Quality Assurance Engineer

US - NJ - Plainsboro, Vacancy ID2019-32612

Career Home Job Search Results Sr. Quality Assurance Engineer

Changing lives. Building careers.

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol IART.

RESPONSIBILITIES

Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

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Performs Quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes. Ensures investigations and root cause analysis are accurate and complete
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Maintain an accurate log of Non-Conformances and CAPAs activities. Tracks, follows-up and assists in the timely closure of NCs/CAPAs.
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Provides hands-on guidance and training to all personnel performing activities within the Quality system.
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Ensure documentation is complete before closure.
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Performs Complaint Investigations and Failure Analyses.
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Assist Quality Systems team as needed to investigate Nonconformances and ensure proper implementation of CAPAs.
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Prepare monthly and quarterly metrics to present at Quality Review meetings.
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Maintains a thorough understanding of the following regulations and guidelines: U.S. Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485:2003, Medical Device Directive (MOD), the Canadian Medical Device Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements.
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Interact and coordinate activities with other departments, external vendors and customers.
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Perform other Quality Systems related duties as required.

QUALIFICATIONS

What are we looking for?

Qualifications

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

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Education: Bachelor's Degree in Science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical)
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Experience:6-9 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.
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Demonstrates knowledge of investigations, root cause analysis, quality systems, the CAPA system and technical writing.
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Demonstrates excellent organizational and communication skills.
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Proficient with the MS Office Suite, TrackWise, and statistical software.
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Must be able to work independently with minimal supervision.

OUR PRODUCTS

We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.

OUR CULTURE

We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas - big and small - are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.

OUR VALUES

We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law at *********************************** | EOE including Disability/Protected Veterans at *************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA at ************************************************* . If you have difficulty using our online system due to a disability and need an accommodation, please email us at *********************** or call us at ************.

Please see our Privacy Policy at *********************************** . Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to our Terms of Use at ********************************* . You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Integra Life Sciences. Contact Us at *********************************** with any questions or search this site for more information.

Copyright 2018 Integra LifeSciences Corporation. All Rights Reserved.

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