Integra LifeSciences Quality Engineer II in Boston, Massachusetts
Quality Engineer II
US–MA–Boston, Vacancy ID2021-37130
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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.”
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
Facilitate the launching of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective.
Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.
Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
Collect, Analyze and report Quality Metrics
Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
Develop, review and approve validations and completion reports for new and existing products, processes and equipment. Provide statistical analysis of the data to support the reports.
Ensure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements.
Formulate detailed product quality plans based on results of risk analysis
Support as required the Quality Management Review Process
Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.
Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.
Identify and implement opportunities for continuous improvement.
Audit internal groups or programs and external vendors for compliance with corporate and international regulatory guidelines.
Interact and coordinate activities with other departments, external vendors and customers.
Work with Product Development team in order to ensure all aspects of Design Transfer activities are being met
As required, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective & Preventative Action(s) (CAPA support)
Aid in the implementation SPC control system with Manufacturing and Quality Control.
Perform other Quality Systems related duties as required.
Perform other duties as required.
What are we looking for?
Education : A Bachelor’s Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology) or equivalent work experience.
Experience: A minimum of 3 – 5 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated product preferred environment. Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Highly proficient in computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations. Able to support manufacturing by analyzing process data and recommending changes to improve quality. Ability to query databases and generate reports. Ability to follow instructions precisely, recognize deviations, and recommend corrective action. Detail-oriented.
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.
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.
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.
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