Key Quality Assurance Role
This is a critical position for a quality engineer to contribute to the development of compliant manufacturing processes.
Responsibilities and Key Performance Indicators:
* Provide technical support during product development, ensuring compliance with FDA, QSR, MDR & EU GMP standards/guidelines for medical devices.
* Utilize advanced quality engineering tools and techniques, including validation protocols (DQ, IQ, OQ, & PQ), cGMP, FMEAs, and DMFs.
* Support the design and implementation of compliant manufacturing processes, ensuring products are operational ready post-validation.
* Apply continuous improvement methodologies and process capability analysis to provide robust defect-free processes.
Requirements:
* Bachelor's Degree in a life science discipline.
* 2-4 years experience in manufacturing, preferably in Medical Devices or Pharmaceuticals.
* Strong organisational and planning skills to plan, execute, and track quality commitments.
* Working knowledge of ISO 13485 and/or Pharmaceutical EU GMP (Eudralex Volume 4).
* Excellent leadership skills, ability to motivate team members.
Additional responsibilities may be assigned from time to time as needed, based on departmental requirements.