Quality Assurance Specialist II
1 day ago
We are seeking a highly skilled Quality Inspector II to join our team at Integra LifeSciences. As a Quality Inspector II, you will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies, and final product.
Key Responsibilities- Perform quality assurance inspections on purchased components, manufactured sub-assemblies, and final product.
- Ensure compliance with overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and other applicable regulatory agencies.
- Measure critical dimensions and perform inspections using various inspection, measuring, and test equipment.
- Determine acceptance or rejection of material or parts based on inspection and testing results.
- Perform first article, incoming/receiving, and in-process inspections of materials or parts.
- Interpret and work within guidelines of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
- Assist in the review and disposition of non-conforming material and customer returned material.
- Maintain accurate and current inspection and/or testing records.
- Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives.
- Promote and participate in continuous improvement initiatives.
- Associate degree preferred.
- 3-7 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
- QA experience in the medical device industry preferred.
- Strong written and verbal communication skills.
- Strong organizational skills, self-directed, strong problem-solving and interpersonal skills.
- Knowledge of CAPA, Validations, Change Control, preferred.
- Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP.
- Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
Integra LifeSciences is an equal opportunity employer, and we are 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.
This site is governed solely by applicable U.S. laws and governmental regulations.
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