Description
Quality Engineer: ValidationDesired qualifications:
* Bachelors Degree in Engineering (Biomedical, Mechanical, Chemical, or Electrical) or a Life Science (Biology, Chemistry).
* Minimum 2 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
* Excellent technical writing skills with a thorough understanding of good documentation practice.
Job description:
* Execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
* Must be able to read and understand engineering P&ID's and turnover documentation.
* Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
* Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
* Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
To find out more about Real please visit www.realstaffing.com