Quality Specialist - Medical Devices

Location Warrington
Discipline: Medical Device
Job type: Contract
Salary: £Up to £35.00 per annum
Contact name: Simon Fowler

Contact email: simon.fowler@sciencesr.com
Job ref: BBBH2987_1632846148
Published: 21 days ago
Startdate: ASAP

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