Senior QA Associate

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
Chicago, Illinois
Posting date: 01 May 2019

ProClinical, in support of our client, are seeking an individual to fill the role of Senior Quality Assurance Associate, based in Chicago, IL.


  • Maintain device history files and master records.
  • Complete cGMP supplier audits.
  • Complete nonconforming material reports.
  • Rework and Re-Inspection Plans.
  • Conduct the quality assurance review of testing data.
  • Review and approve device history records.
  • Perform complaint investigation and root cause analysis.
  • Complete post market surveillance reports.

Skills and Qualifications

  • BS in an allied scientific field and 3 + years medical device or pharmaceutical experience.
  • Experience with medical laser systems.
  • Working knowledge of 21 CFR 820 and ISO 13485.
  • Proven track record of proven flexibility and growth with the ability to adjust to changing roles.
  • Experience working in a multi-functional environment and on multi-functional teams.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.