Description
My client is now recruiting for a Quality Manager to join the successful UK manufacturer of Class III implantable Medical Devices - £45,000-£55,000Responsible for the day-to-day operation and running of the Quality Management system. These will include the following listed below and other duties may be assigned depending on the needs of the business;
- Develop and maintain the QA system
- Plan and manage internal and external auditing
- Develop purchasing specifications
- Approval of incoming material certificates process
- Maintain quality records and sterilisation records including bioburden
- Suggest improvements to the quality system and assist in its development
- Deputise for the QA and RA Director where permitted by procedures
- Manage the Quality Engineers
- Day to day running of the: Quality management system in line with documented procedures
- CAPA system in line with documented procedures
- Complaints system in line with documented procedures
- Auditing system in line with documented procedures
- Validation system in line with documented procedures
- Non-conformance system in line with documented procedures
- Supplier approval and monitoring system in line with documented procedures
- Issue Quality Alerts in line with documented procedures
- Responsible for cGMP training for all employees
- Attend Material Review Board (MRB) meetings
- Attend Audit Planning Committee meetings
- Attend Change Control Committee meetings
- Chairing monthly and annual Management Review Meetings
- Conduct all activities in accordance with ABHI, Eucomed and Company policies with particular regard to Healthcare Compliance and Bribery Act regulations.
Skills and experience:
- Strong Quality Assurance background - preferably in the medical industry
- Thorough understanding of CE marking, EU device directives and FDA
- Working knowledge of Microsoft Office
- Good written and verbal communication and interpersonal skills
- Ability to work effectively with people at different levels
- Detailed, finisher and logical
- Ability to manage and motivate people effectively, enabling them to perform to the best of their ability, achieving maximum output and ensuring employee engagement.
- Line management experience
- Demonstrable experience of auditing
- Degree in Science or Engineering
- Report writing skills
- IRCA Lead Auditor would be a benefit.
If you think that you have the correct experience then please send me your up to date CV and I will be in touch shortly to discuss further.