Quality Assurance Specialist

3 weeks ago


Bloomington, Indiana, United States Cook Group Full time
Job Overview
Cook Group is seeking a highly skilled Senior Quality Engineer to join our team. This role is responsible for performing quality mentor and reviewer duties for CAPA and RIC activities, ensuring compliance with external and internal quality standards. Key responsibilities include interface with internal and external groups on quality-related issues, conducting risk-based decision making and effective resolution of issues, planning, reviewing, and approving change requests, and performing quality assessment of root cause analysis of product or process CAPAs.

The ideal candidate will have an Engineer or Technical Life Science degree, demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971), and professional certification (e.g. ASQ, Six Sigma) preferred. Proficiency in statistical, quality and continuous improvement methods and tools, as well as Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook), is required. Strong organizational skills, critical thinking, and attention to detail are also essential.

The salary for this position is estimated at $80,000 - $120,000 per year, depending on experience. Work is performed in a general office environment with occasional time in manufacturing and biohazard lab settings. Regular sitting and close visual acuity are required, with occasional travel possible.



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