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.
- 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.
- 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.