Cook Regentec LLC
Quality Assurance Specialist (Finance)
Posting Date 1 month ago (10/8/2021 5:34 PM)
Requisition ID 2021-9664 Job Location(s) Bloomington IN United States Travel Less than 10% Shift Type First Position Type Full Time Company Cook Regentec LLC Category Quality
Overview
Cook Regentec ( www.cookregentec.com ), a Cook Group company, was founded in 2015 as an incubator and accelerator for emerging medical technologies. Our primary focus today is to innovate breakthrough medical devices for the preparation and delivery of advanced therapeutics, including cell, gene, and immunotherapies.
The Quality Assurance Specialist will work under the Cook BioDevice (CBD) Quality Management System to ensure the delivery of safe and effective products through completion of investigation management, risk management, product release, supplier qualification, disposition of nonconforming products, development report approvals, internal and external audits, and document control and training. The QA Specialist will help maintain the Cook BioDevice Quality Management System to ensure compliance with all relevant regulatory requirements, including but not limited to ISO 13485, ISO 14971, and 21 CFR 820.
This is a remote position.
Responsibilities
Qualifications
Required Qualifications
Preferred Qualifications
Physical Requirements:
• General office environment
• Must be able to sit for long periods of time
• General office environment
• Must be able to sit for long periods of time
• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Requires close visual acuity for working with computers
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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."
Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.