Product Quality Analyst

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Listing Info

We are seeking a Product Quality Analyst with one of our important clients.

Jr. Level: Responsible for analyzing Company product complaints to determine potential regulatory reportability while maintaining the quality processes related to Company post-market product complaints to ensure compliance of all applicable Corporate and Divisional policies and procedures. Demonstrates thorough understanding of quality management standards as outlined in Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs) and ISO 13485. Actively participates in departmental process improvements and effectively communicate shared knowledge to contribute to overall success of the Company. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Manages individual complaints on various product lines, from opening to closing. Performs accurate and timely data entry in corporate complaint database. Coordinates complaint investigations, including determining investigation strategies, as needed with internal and external resources. Communicates directly with Company customers regarding reported complaints and resolutions. Analyzes complaint data to identify any trends, and provides information to department management and other personnel that may lead to a Corrective Action Request. Works with other departments and vendors on known or emerging issues to resolve quality problems that may impact patient safety. Responds to technical or medical information requests from healthcare professionals, Company personnel and consumers. Assists global Company departments by providing ad-hoc reports related to product complaint trending and investigations.

The Ideal Candidate Must Possess The Following

Junior Level: Bachelor's degree in Life Sciences or similar field plus related work experience, or an equivalent combination of education plus work experience. Minimum 2 years in medical device and / or pharmaceutical industry, preferably in a complaint handling position. Medical terminology/ophthalmic knowledge desired. Will perform this job in a quality system environment. Proficient computer skills in Excel and Word, with a good understanding of database management of complaint records. Prior experience using complaints processing software (such as CATSWeb) is desirable.


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