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The Lead Quality Inspector serves as a Lead Associate, Quality Inspector for the Plainsboro Manufacturing Site, Collagen Manufacturing Center (CMC). The lead associate is responsible for performing and/or scheduling quality assurance inspections on purchased components, manufactured sub-assemblies and final product. Expectations are to be familiar with and be able to measure critical dimensions as well as to train new quality inspectors and provide guidance to current quality inspectors. Lead Associate, Quality Inspector will perform all duties in accordance with the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies.

Job Responsibilities

• Oversee daily activities in the QC department.

• Prepare the QC Inspection schedule to ensure that all manufacturing areas are covered in order to meet production schedule.

• Reports any non-conformances in timely manner.

• Support NCs and CAPA investigations as required.

• Assist with product flow between departments.

• Interface with Manufacturing department in order to coordinate inspections of completed product to ensure the inspections are done in a timely manner.

• Initiate and /or propose revisions to standard operating procedures involving new processes or process improvements.

• Train QC Inspectors as required.

• Perform inspections (incoming, in-process, first article, etc.) by using a variety of inspection measuring equipment to determine acceptance or rejection of material or parts.

• Interpret and work within the guideline of drawings, specifications, charts, procedures, and other date to determine product or material acceptance.

• Read and interpret sampling plan as per the American National Standard Institute (ANSI).

• Oversees physical and electronic quarantine locations.

• May also perform other related duties, responsibilities, and special projects as assigned.

DESIRED MINIMUM QUALIFICATIONS

• Minimum of 1-2 years' experience in document and promotional materials management using electronic document management systems or with manual systems using electronic document storage.

• Minimum of 1-2 years’ experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred.

• Capable of both written and verbal effective communication skills.

• Proficient in the Microsoft Office suite of products.

• Proficient in Oracle R12/Agile preferred.

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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