Quality Assurance Specialist

Posting Date 3 weeks ago(10/8/2021 10:34 AM)
Requisition ID
Job Location(s)
Bloomington IN United States
Less than 10%
Shift Type
Position Type
Full Time
Cook Regentec LLC


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.



  • Perform document control functions which may include ensuring approved documents such as Risk Management Files, Product Specifications, etc., maintain a state of control and are updated and released
  • Write, update, complete, archive, and track QMS documents and records
  • Participate in the review and approval of investigations related to CAPA, Feedback, and Complaints
  • Review documents for approval; these may include engineering development reports, batch records, and validations
  • Ensure Training requirements are communicated to personnel and maintain records of completion
  • Assist with new supplier qualifications and current supplier re-qualifications
  • Complete change control initiation, evaluation, and approval as needed for changes impacting the QMS
  • Assist as needed with other company duties, as deemed appropriate
  • Communicate to Management the progress and status of quality system processes in relation to the QMS system
  • Foster and maintain a workplace culture respectful and supportive of individual differences



Required Qualifications

  • Bachelor’s Degree
  • 2+ years of experience in a Quality-related function within a regulated industry such as pharmaceutical, medical device, or biologics
  • Excellent and effective English written and oral communication skills
  • Experience working with cross-functional stakeholders
  • Ability to work in both collaborative and independent environments with minimal supervision


Preferred Qualifications

  • Working knowledge of FDA current Good Manufacturing Practices and 21 CFR 820
  • Experience working with ISO standards such as ISO 9001, ISO 13485, and ISO 14971
  • Experience with electronic QMS systems


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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