Quality Engineer

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.

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