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Integra LifeSciences Quality Engineer II in Boston, Massachusetts

Quality Engineer II

US–MA–Boston, Vacancy ID2020-34896

Career Home › Job Search Results ›Quality Engineer II

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 oversee/perform each essential duty satisfactorily. Other duties may be assigned.

  • Assist or lead complaint handling activities (e.g., investigations).

  • Assist or lead in the identification and implementation of CAPA.

  • Assist or lead Control of Nonconforming Product process activities (e.g., MRB review/approval).

  • Assist or lead the execution of Risk Management activities.

  • Support new product development and production (e.g., Change Order review and approval, participation on design teams).

  • Provide support necessary for supplier controls (e.g., SCARs, supplier audits).

  • Identify statistically based sampling plans for inspections and validations.

  • Aid in the implementation SPC control system with Operations team.

  • Support validations/qualifications for new and existing products, processes and equipment.

  • Establish and maintain Quality Management System procedures related to areas of responsibilities.

  • Ensure compliance with cGMP, GLPs, QSR, ISO13485, MDD/EU MDR, and other applicable regulations/ standards.

  • Support Internal Audit program.

  • Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.

  • Identify and implement opportunities for continuous improvement.

  • Collect and report metrics and data as required.

  • Perform other duties as assigned by Site QA Leader.

QUALIFICATIONS

What are we looking for?

Qualifications

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

Education & Experience:

  • BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.)

or 3-5 years of working experience in Quality Assurance/Control.

  • Minimum of 1-3 years’ experience in a regulated industry, preferably Medical Device Industry

  • Working knowledge of medical device regulations (including FDA QSRs, ISO13485).

  • Understanding ofQA Engineering related QMS elements includingDesign Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product).

  • Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).

  • Experience with CAPA processes including investigational techniques.

  • Understanding of Complaint Handling processes, especially investigations.

  • Understanding of Risk Management regulations and application (ISO14971).

  • Knowledge of statistical sampling and analysis.

  • Ability to communicate effectively (both written and oral) using English (or local language).

  • Demonstrated ability to work cross-functionally in a team environment.

  • Ability to work independently with little supervision.

  • Familiar with the MS Office Suite, including Microsoft Visio and Project.

  • Must be able to observe company policies and safety procedures at all times.

  • Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.

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 https://www.eeoc.gov/laws/index.cfm | EOE including Disability/Protected Veterans at https://www.eeoc.gov/eeoc/publications/adaveteransemployers.cfm 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 https://www.eeoc.gov/eeoc/publications/fs-ada.cfm . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

Please see our Privacy Policy at https://www.integralife.com/privacy . 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 https://www.integralife.com/terms . 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 https://www.integralife.com/contact with any questions or search this site for more information.

© Copyright 2020 Integra LifeSciences Corporation. All Rights Reserved.

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