Quality Engineer

Quality Engineer - $90-105K + 10% Bonus – Medical Devices & Pharmaceuticals Mfg - Providing Quality Assurance oversight and assessment of operational activities in Production, Validations, and Technical Services projects. Providing guidance and executing internal and external audits to ensuring processes and equipment validations meet regulatory standards and are cGMP compliant. Serves as the QA representative on Validation and Technical Services projects. Liaison to process and equipment validations for QA/QC laboratories, IS, Manufacturing, and Engineering. Reviewing and approving equipment validation documentation (e.g., protocols, deviations, and final reports). Generating Capital Expenditures (CE’s) and documentation for Quality Assurance validations projects and URS and FRS requirements. Supporting change control activities associated with processes and equipment validations. Managing and coordinating QA support for new and existing process equipment validation implementations. Providing CSV oversight based on the education and training of the individual.

*LI-CF1

Bachelor’s degree in the Sciences, Engineering, Statistics, or a related field preferred. Three (3) years’ of Medical Devices and/or Pharmaceuticals manufacturing experience with a minimum of one (1) year experience in a relevant area such as Quality Assurance, Validation or Technical Services. Strong user of Microsoft Office (Word/Excel/PowerPoint). Functional user experience with Statistical programs like Minitab preferred. Experience working in a GMP regulated environment preferred. Experience in an aseptic manufacturing environment preferred.