Our expanding manufacturing client are recruiting for an experienced Quality Engineer to join their growing operation.
We are looking for an exceptional candidate, with a minimum of 3 Years experience working within a manufacturing site or Quality department, who possesses strong knowledge and experience in the use of Quality tools and techniques (cause and effect, pareto analysis, SPC and continuous improvement techniques).
Assist in the maintenance of the Quality, Environmental, Health and Safety and LSAS management systems.
Manage the control and revision of documentation through electronic document control system.
Maintenance of the ECO process for the Quality department.
Maintenance of Internal Audit schedule, alongside carrying out internal and external audits.
Maintenance / Support Corrective and Preventative action process.
Compilation of GOP's, SOP's and work instructions and supporting documentation.
Maintain awareness of pending industry changes, trends, and best practices and assess the potential impact of these changes on our organisational processes.
Create training presentations/questionnaires and deliver training sessions where required.
Liaise with other departments / sites to investigate, analyse and resolve issues arising from design and manufacture, and manage the required actions within an appropriate time-frame.
Monitor and report on Quality KPI's and take appropriate action where required.
Maintenance of the customer complaint process.
Maintenance of the vigilance process, Lead projects, Post Market Surveillance.
Monitoring of the clean-room and managing (carry out when required) goods inwards.Essential Experience:
Formal qualifications in relevant engineering, science, or management system discipline.
Highly developed computer literacy e.g. excellent application of Microsoft packages.
Competent with technical drawings and specifications.
Excellent problem solving techniques.
Qualified to perform ISO 9001 and ISO 13485 Audits.Desirable Experience:
Experienced in the Medical Device sector.
Experienced in dealing with regulatory authorities and certification bodies.
Strong understanding of EMS & LSAS (Labour Standards Assurance System).
Experience in producing written reports and making presentations.
Experience working with Quality Management software.
Experience of Medical Device Single Program (MDSAP).
Knowledge of 21 CFR Part 820.
Knowledge of Medical Device Regulation (MDR) 1017/45.
Knowledge of ISO 14871 Risk Management.
Qualified to perform MDD / MDR, LSAS, ISO 14001 and ISO 45001 Audits.
Project Management qualification or experience.
FMEA's and Control Plans.Our client offers an excellent working environment, competitive salary (depending on experience level) and excellent benefits
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Tagged as: Mid Glamorgan
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