Integra LifeSciences Quality Engineer II in Boston, Massachusetts
Quality Engineer II
US–MA–Boston, Vacancy ID2020-34896
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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 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.
What are we looking for?
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.
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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