Lead Quality Systems Developer
* We are looking for a Lead Quality Systems Developer to develop and maintain quality systems in compliance with ISO 13485:2016 and 21CFR Part820.
* The ideal candidate will manage document control, represent the quality function, and participate in risk management.
* Liaise with technical operations, prepare quality metrics, and ensure customer complaints are addressed.
* Implement CAPA systems, manage computerised system validation, and maintain internal audit systems.
* Support supplier management, prepare reports, and support continuous improvement of quality processes.
Requirements:
* A Bachelor's degree in Science or Engineering is required.
* The ideal candidate has at least 8 years of experience in quality engineering or regulatory roles.
* Excellent written, interpersonal, and presentation skills are necessary.
* The ability to deliver results with minimal direction and prioritise critical objectives is essential.