Job Overview
IQ Endoscopes Limited is seeking a highly skilled Senior Quality Engineer to drive quality and compliance initiatives in the development and manufacturing of endoscopic medical devices.
About the Role
This challenging role involves leading risk management activities, collaborating with design and development teams, and overseeing sterilization validation processes to ensure product safety and effectiveness.
Main Responsibilities:
* Support the development of new and existing product portfolios while ensuring adherence to quality standards.
* Develop and implement effective risk management strategies in line with ISO 14971 guidelines.
* Collaborate with cross-functional teams to validate sterilization processes and ensure product compliance.
* Investigate non-conformities, complaints, and market feedback to identify areas for improvement.
* Liaise with stakeholders to facilitate smooth design transfer activities.
Requirements:
* Minimum 4 years of experience in a similar role within medical device environments.
* Degree-level qualifications in a relevant science or engineering discipline.
* Strong understanding of ISO 13485, ISO 14971, UK MDR, and US FDA 21 CFR Part 820 regulations.
* Authorisation to work in the UK.
What We Offer:
We provide a competitive salary, hybrid working arrangement, and a comprehensive benefits package, including health and wellbeing support, pension scheme, and refer-a-friend bonus.
Our company culture is built on passion, innovation, empowerment, inclusion, and transparency. We strive to create a workplace where everyone feels valued and supported.