A top Biopharmaceutical company is looking for a Quality Assurance Engineer to join their team! Take advantage of this global opportunity!
- Assures that the manufacturing process is in compliance with cGMP Quality Management Systems.
- Confirm accuracy of QC Inspection Plans and Standard Test Procedures.
- Act as QA representative on New Product Development and Engineering Projects.
- Implement new and improved measurement, gauging, and data acquisition systems to improve inspection of measurement systems.
- Support Validation of equipment, processes, and molds.
- Review Validation Protocols (IQ, OQ, PQ)
- Develop Validation Protocols and Reports by collaborating with Engineering Department.
- Support CAPA
- Facilitate CAPA investigations, non-conformance, audit non-conformances, and more.
- Participate in PPI projects.
- Other duties as assigned.
- Bachelor of Science in Engineering
- 5+ years in Quality Engineering.
- Plastic Product manufacturing experience
- Medical device manufacturing experience in compliance to FDA Quality System Regulation, ISO 13485:2016 (a plus), EU Medical Device regulation.