Quality Engineer
Posted 1 week ago by Kinetica
£50,000 Per year
Undetermined
Onsite
North Yorkshire, England, United Kingdom
Summary: The Quality Engineer role is a site-based position in North Yorkshire, UK, focused on the medical device industry for a 6-9 month contract. The engineer will lead validation programs, support quality assurance initiatives, and ensure compliance with regulatory standards. The position requires immediate availability and extensive experience in quality engineering within the medical device sector. Strong communication skills and knowledge of ISO 13485 are essential for success in this role.
Key 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
Key Skills:
- 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
Salary (Rate): £50,000.00 yearly
City: North Yorkshire
Country: United Kingdom
Working Arrangements: on-site
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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.