We are looking for an experienced Quality Manager to join a dynamic Engineering company developing an array of products for the medical / healthcare industry. The role will focus on the Quality Management System, supporting global subsidiaries as well as departments within the company including R&D, Product Management, Sales, Customer Care, Marketing, Manufacturing.
As the Quality Manager / Quality Management System Manager you will be a key member of the Engineering team.
Quality Manager/ Quality Management System Manager responsibilities:
Identifying and managing product regulatory standards, managing the Quality Management System for medical/healthcare products.
Keep up to date with new standards in worldwide markets, manage and maintain training records for all relevant documents and procedures.
Implement and maintain QMS requirements to meet ISO9001, ISO14001, ISO13485 and 21 CFR 820.
Internal and external audits, resolve non-conformities, support supply chain, assist in Risk management.
Report all QMS activity and represent QMS in Management reviews.
Work with internal teams to ensure compliance during product development & test, creating clear procedures.
Ensure management reviews are carried out and documented, maintain personal and professional development and training.
QMS Manager Requirements:
Technical/Engineering Degree (BEng, MEng, BSc) or HNC/HND in Mechanical Engineering, Production Engineering, Industrial Design, Quality Assurance etc.
Knowledge of international standards particularly ISO 9001, ISO14001, ISO13485 and 21 CFR 820 and at least 3 years experience in a similar quality management role.
Recent audit and training experience.
Good written English and ICT skills.
Great attention to detail and planning skills
Risk Management experience for business processes
Experience of FDA inspections
Auditor`s certificate (preferably ISO 13485 or 9001).