Integra LifeSciences QA Specialist II, 2nd Shift (2pm-10:30pm) in Boston, Massachusetts
QA Specialist II, 2nd Shift (2pm-10:30pm)
US–MA–Boston, Vacancy ID2021-36915
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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.”
The Quality Assurance Specialist II oversees requirements for continuing cGMP training to keep all employees aware of their responsibilities and changing requirements for cGMP compliance. Works collaboratively with Manufacturing, Engineering, Quality Control, and other functional experts to support all daily operational activities. Functions as an information source to various company departments when special and critical quality issues occur. Conducts internal audits of production facilities assuring company standards and product integrity are maintained. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with manager and functional experts on special department projects. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system. Performs the essential duties and responsibilities as listed in section below.
Writes and revises operating procedures
Conducts training for staff at all levels as it relates to quality systems
Processes document change requests and training records
Compiles quality metrics for daily/weekly/monthly reporting and reports metrics to site management
Compiles information for Quality Management Review
Conducts inspections of materials
Reviews records for compliance such as inspection reports, test records, and Device History Records
Updates component, product, and documentation databases
Reviews validation/qualification reports for GMP and quality system compliance
Conducts complaint investigations
Conducts CAPA investigations, proposes corrective and preventative actions, and conducts verification and effectiveness reviews
Investigates and reviews Nonconforming Material reports and presents reports/metrics during periodic meetings
Evaluates supplier quality performance and conducts periodic evaluations of suppliers
Conducts internal audits
Participates in audits/inspections by customers and regulatory agencies and compiles corrective and preventative action responses
Other duties may be assigned as necessary
What are we looking for?
Associates Degree with related work experience is required. A Bachelor’s Degree is preferred.
A minimum of 4 years’ experience in a Quality/Regulatory Compliance environment.
Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.
Moderate computer competence, including experience with database and Microsoft Office.
Knowledge of QA terms, tools, and methodologies.
This role is based in our South Boston facility, with free garage parking!
Interested in moving to Boston? We offer relocation!
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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