Job Description
Quality Engineer Position at a World-Leading Medical Technology Company
We are seeking an experienced Quality Engineer to join our team in Oxford, UK. As a key member of our global medical device organisation, you will play a crucial role in developing innovative solutions that improve patient outcomes.
This is an exciting opportunity for a motivated and results-driven individual to oversee quality engineering, process control and inspection efforts while embodying our core values of innovation, evidence, integrity, teamwork, respect, and commitment to transplantation.
The successful candidate will be responsible for:
* Providing leadership and guidance on quality engineering best practices to the department and organisation
* Identifying opportunities to ensure compliance with applicable internal and international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485
* Defining and implementing process control and monitoring systems to guarantee product quality and consistency
* Leveraging influential peer leadership skills to drive quality initiatives and lead cross-functional teams
* Supporting non-conformance and real-time data management within the quality system
* Conducting risk assessments and failure mode and effects analysis (FMEA) to mitigate potential issues
* Maintaining subject matter expertise in relevant procedures and specifications related to current job specifications
* Participating in and supporting external audits, such as BSI and FDA
* Fostering continuous quality compliance and proactive improvements through effective collaboration with cross-departmental functional teams
* Developing and executing activities to resolve decreases in performance and maintaining effective quality metrics
* Championing Quality, Six Sigma, Lean and disciplined problem-solving methodologies
To be considered for this position, you should have:
* A Bachelor's degree in an engineering discipline or equivalent
* Minimum 3 years' experience working within quality at a medical device manufacture
* Experience with Class II or III devices
* Expert knowledge of cGMP, 21 CFR 820, ISO 13485, and 14971
* Lead ISO 13485 certification is highly desirable
Estimated Salary: £60,000 - £80,000 per annum, depending on experience.