Quality Engineer – Yorkshire, UK – Medical Device – 6-9 Month Contract
About the Company:
We are looking for an experienced Quality Engineer from the medical device industry to start at short notice on a 6 – 9 month contract. The role is site based 5 days a week.
Responsibilities:
* Lead and implement validation programmes, including process, cleaning, sterilisation, and computerised systems validation
* Develop and review validation protocols and reports, ensuring robust statistical analysis and data integrity
* Generate and review equipment qualifications and Gauge R&R studies
* Support site qualification activities aligned to the Master Validation Plan
* Investigate complex quality and compliance issues, driving root cause analysis and CAPA implementation
* Lead risk management activities (e.g. FMEA) and integrate risk processes across the product lifecycle
* Provide quality engineering support to projects, ensuring timely and compliant delivery
* Drive continuous improvement initiatives to enhance systems, processes, and efficiency
* Support maintenance, calibration, and equipment compliance systems
* Participate in internal and supplier audits, ensuring regulatory compliance
Requirements:
* Significant experience working as a Quality Engineer in the medical device industry.
* Availability to start with short notice.
* Ability to work onsite 5 days per week.
* Eligibility to work in the UK for a full duration of the contract.
* Excellent communication skills.
* A good knowledge of ISO 13485.
* Equipment and process qualification and validation experience.