We are seeking a seasoned Device Development Assurance Specialist to join our global team. In this role, you will play a critical part in the design, development and commercialization of device technology solutions.
This position involves supporting and guiding device development programs through the design and development lifecycle for combination products. You will ensure compliance with design control requirements outlined in Quality Management Systems and relevant regulations.
* You will establish, maintain and provide guidance on Design History Files for various program types – in-house design authority, collaborative development, and acquired programs.
* You will collaborate with affiliate sites, collaborators and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
Key Responsibilities:
The successful candidate will have:
* Degree or Master's in engineering or science/life science
* Industry experience in Medical Device or Pharmaceutical (with devices)
* Proven experience in similar level/general experience in industry
* Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment
* Experience in the implementation of device design controls and ISO/FDA requirements as applicable to device design
* Demonstrated understanding of GMP, Quality Management System, and relevant Regulations (e.g. 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971)
* Strong problem solving and analytical skills
* Possess knowledge of core manufacturing / laboratory operation principles
* Excellent communication skills; clear and concise in communications with External and Internal partners