Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Quality Control Inspector II will be responsible for inspecting and testing raw materials, manufacturing materials, packaging, work-in-process (WIP), and finished goods at various stages of production process. Selects random samples for inspection and testing at specified stages such as incoming or in production process, and inspects for variety of qualities per the standard operating procedure. Records results and assesses against acceptance criteria. Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consults with supervisor to resolve quality, production, and efficiency problems. Functions in conjunction with supervisor and functional experts on special department projects. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system.
Primary responsibilities are to:
Inspect raw materials, manufacturing materials, packaging, WIP and finished goods per standard operating procedures.
Sample and perform chemical assay of solutions per standard operating procedures
Assesses inspection and test results against acceptance criteria
Documents activities in device history records
General laboratory maintenance
Complies with current Good Manufacturing Practices and all applicable standards and regulations
Maintains a working inventory of all components, materials and solutions
May assist as needed in execution of test method validations
May assist with document review and revision
Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs)
Investigates and documents non-conformance reports
Perform other duties as required
Qualifications:
High School Diploma or equivalent
A minimum of 2+ years in Quality Inspection, Quality Control or Quality Assurance. Experience in medical device, pharmaceuticals, or other regulated industry preferred.
Experience with chemical testing.
Ability to assess results against acceptance criteria.
Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
Working knowledge of current Good Manufacturing Practices.
Familiarity with application of FDA and ISO quality standards in a government regulated industry.
Proficient computer skills, including experience with database applications and Microsoft Office.
Working knowledge of standard laboratory practices and safety.
Detail-oriented.
Excellent organizational and time management skills.
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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EEO Is the Law | EOE including Disability/Protected Veterans
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. 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.
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