US-NJ-Plainsboro: Quality Control Inspector

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 30-Oct-2008

Senior Quality Assurance-Quality Control Inspector

Summary:

The Senior Quality Assurance Inspector coordinates and prioritizes projects. Supports the control and accuracy of documents that will ensure that company products of the highest quality are developed, produced, controlled and distributed according to the requirements of corporate policies, regulations of the U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device Conformity Assessment System, and other applicable regulatory agencies and requirements.

Essential Duties and Responsibilities:

* Review Device History Records (DHR) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for product release. * Track errors in DMR’s. * Initiate Certificates of Compliance for Integra LifeSciences Corporation OEM partners and customers. * Oversee review and approval of in-house computer generated labels. * Review QC inspection results and maintain an accurate filing of these results * Perform inspections of incoming components and perform inspection of devices manufactured for human use at specified points in the packaging and labeling process (20% of time). * Assist in training new associates according to QSR and company SOP’s.

Minimum Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

* High School Diploma; 2 year technical degree preferred * 2 to 5 years experience in Quality Assurance environment in medical device, diagnostics or pharmaceutical industry with general knowledge of FDA/QSR regulations; relevant GMP/GLP experience; ISO 13485 -2003, CMDR and Medical Device Directives * Must have positive interpersonal skills and team focused attitude to work with other associates in the QA/QC department and associates in other departments as a part of a team effort in reaching company goals. * Demonstrate high attention to detail, good organizational and communicational skills. * Must be able to work independently with minimal supervision.

For more information, please write to us.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com