Description:
This role includes driving risk management activities, supporting design and development processes, and overseeing sterilisation validation to ensure product safety and effectiveness. Through root cause analysis and continuous improvement initiatives, the Senior Quality Engineer collaborates with cross-functional teams to deliver high-quality, safe, and compliant endoscopic devices that meet industry standards and enhance patient outcomes and leads by example acting as a natural ambassador for quality and compliance across departments.
Your main focus will be
- Directly support with Design and Development (Design Control) of new and existing product portfolios for intended target markets as applicable, predominantly, UK, EU, US and Australia.
- Lead, generate and maintain the Risk Management in accordance with ISO 14971 for all products in IQE’s portfolio.
- Support sterilisation validation and requalification activities in collaboration with relevant teams and third-party organisations.
- Support non-conformance, complaints, change control and market feedback process in conjunction with Compliance.
- Support Design Transfer activities.
- Support Quality, Regulatory and Clinical function as needed.
What you must have
- At least 4 years of experience in a similar role the majority of which needs to be within medical device environments
- A minimum degree level or equivalent qualification in a relevant medical science, science or engineering discipline, preferably biomedical or bioscience
- Experience of working fully in line with ISO 13485, ISO 14971, UK MDR, and US FDA 21 CFR Part 820
- Experience working within Design Control frameworks, i.e. 21 CFR Part 820.30 and ISO 13485 Clause 7.3
- Experience within a manufacturing environment of at least EU Class IIa devices
- Authorisation to work in the UK. We are unable to provide sponsorship at this time