Kinetica
Quality Engineer
Wales
£40k – £50k/yr
Posted about 17 hours ago
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Quality Engineer – South Wales, UK – Medical Device – 6 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 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.
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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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Skills
Quality Engineering
Validation Programs
Statistical Analysis
Data Integrity
Equipment Qualification
Gauge R&R Studies
Root Cause Analysis
CAPA Implementation
Risk Management
FMEA
Continuous Improvement
ISO 13485
Medical Device Industry
Compliance
Auditing
Calibration
Location