Be conversant with ISO 14001;. ⢠Be conversant with the Medical Device and Personal Protective Equipment Directives an
Quality Manager The ideal person will:
Be educated to degree level, preferably in an technical, engineering or science discipline; Be numerate with a basic knowledge of statistical methods; Have extensive knowledge of ISO 9001 and EN 13485, preferably having implemented systems in other companies; Be familiar with the transitional requirements to ISO 9001 and EN 13485 and the implications for existing systems; Be conversant with ISO 14001; Be conversant with the Medical Device and Personal Protective Equipment Directives and the CE marking process; Be conversant with GMP requirements for the pharmaceutical industry; Have experience in the application of different problem solving techniques; using risk-based thinking and corrective actions Have experience of conducting first and second party audits and hosting third party audits; Have good interpersonal, verbal and written skills; Be capable of adopting training and leadership roles in multidiscipline groups.
Duties will include:
Steering the company through the change from ISO 9001:2008 to ISO 90001:2015 certification; Maintenance and improvement of our certified quality management system; Acting as a key member of the company’s Continuous Improvement Team; Training of employees in the requirements of new or modified SOPs; Conducting internal and supplier audits; Managing the customer complaints procedure to bring timely investigation and conclusion to any issues arising; Liaising with suppliers and customers on quality and regulatory issues; Liaising with our Notified Body on certification issues; Liaising with our manufacturing plant in Malaysia; Producing analytical reports of quality data for in-house use; Organisation of and participation in Management Review meetings; Management of the company CAPA system.
For further information please contact:
[email protected] 