Quality Specialist - 9 Month Contract - Medical Devices - Warrington - c£35 per hour
Location: Warrington WA1
Salary Range - circa £35 per hour - negotiable depending on exp in Medical Device Quality Management Systems.
Details/Brief - This would suit a Quality Specialist, Senior QA, QA Lead, Project QA QA who has a solid Experiencing in ISO13485/CFR part 820 & ...
has the ability to be parachuted into an area such as Goods In/Warehouse
lead a workstream to map all QMS processes
Identify areas of concern (we already know many of these areas)
Remap business effective & compliant processes
Train all staff in the area and work with the QA team here in establishing in the QMS and setting up appropriate go forward training packages
some knowledge of IVD Regulations would be useful - it would be very hands on.
Position Summary;
Assists with QMS processes ensuring compliance with ISO13485/CFR Part 820/Global and Corporate Policies - seeking continuous improvement and promoting all aspects of the QMS.
Works with Manufacturing and QA team focusing on sustaining improvement projects & new process design to improve efficiency, adherence to process and compliance with the emphasis on ISO13485/CFR Part 820/IVDR requirements.
Minimum Requirements/Qualifications of the Quality Specialist;
Degree in a scientific discipline or equivalent experience in a relevant discipline.
Experience of ISO14971/FMEA/PFMEA a must.
Experience with Quality Improvement Tools (5 Why/pareto analysis/Run Charts).
Experience of ISO13485/CFR Part 820 is a must - knowledge of IVDR would be useful.
Excellent communication and report writing skills.
Ability to recognise deviation from requirements and understanding risks when decision making.
Experience of office packages and general computer skills - knowledge of SAP/Agile an advantage
Ability to challenge existing approaches to compliance in order to seek improved ways of working.
Ability to coach and influence others is essential.
Must attend Warrington Operations UK for at least 3 days in any working week.
Please apply now or contact Simon Fowler at Science Solutions
