Document Control / Quality Assurance

Prodesse, Inc is biotechnology firm that develops, manufactures and distributes multiplex PCR reagents for the identification of infectious disease agents.  Prodesse also operates a CLIA lab to offer services to local hospitals using its in-house developed and validated assays.



Job Description/Summary: In support of 510(k) cleared to market and CE Marked products, Document Control / Quality Assurance will be responsible for: 

·  Controlling documents and records

·  Reviewing Device History Records

·  Tracking and trending for management review

·  Assisting in product registrations and submissions

·  Opportunity for reviewing and approving nonconformance reports and corrective actions and participating in internal audits


We are looking for detail-oriented, self-starting, multi-tasking individuals who are eager for an opportunity to contribute to the company’s success.


Minimal Requirements: BS in biology, microbiology, molecular biology or related field.  Demonstrated proficiency in word processing plus 2 years experience in a FDA and ISO compliant quality management system preferred.


This is a full-time, permanent position.  Benefits include paid vacation and sick time, medical and dental insurance, and a competitive salary. Equal Opportunity Employer.