Integra LifeSciences QC Analyst II in Boston, Massachusetts
QC Analyst II
US–MA–Boston, Vacancy ID2021-38509
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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.”
Perform chemical assay of solutions as well as general laboratory maintenance
Inspection and testing of raw materials, intermediates and final product
Environmental monitoring of clean rooms and water system
Develops and revises SOPs and trains appropriate employees
Maintains a working inventory of all components and archived materials and solutions
Writes and executes testing studies of finished products and components
Assist as needed in test method validation, implementation, and execution
Provides database support, generate reports and analyze process data
Assists Quality Assurance in document review and revision
Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs)
Investigates and reviews Nonconforming Material reports
Assist in preparing for and participating in FDA audits, customer audits, etc.
Demonstrate excellent organizational and time management skills
Perform other duties as required
What are we looking for?
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
Bachelor’s Degree in the biological or chemical sciences or equivalent with related work experience is required.
A minimum of 2-4 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. Quality Certification (e.g. CQE, CQA, Six Sigma) preferred.
Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
Experience with performing Instron testing preferred. Working knowledge of standard laboratory practices and safety.
Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
Exercises sound judgment and decision making when problem solving
Experience working in ISO Class 7 cleanrooms preferred
Experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations
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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