Terumo Aortic requires an experienced Quality Engineer, the successful individual will be required to Support key Quality processes to ensure compliance with required regulations and company policies and procedures. This is an exciting role to join a truly global company during a time of growth and expansion.

Key Duties

• Management of the Internal Quality Audit Programme and performing Internal Quality Audits to ensure compliance per schedule
• Support site audit readiness for regulatory and customer external inspections.
• Maintenance of up-to-date cGMP/GDP training materials and delivery of quality management system training including FDA preparation and related requirements
• Ensure that all related processes and procedures meet the requirements of all applicable regulatory standards including the EU Medical Device Regulation (MDR); ISO 13485, 21 CFR Part 820, MDSAP requirements and other regulations as appropriate
• Provide consultation and advice on quality related subjects, supporting business and department objectives whilst ensuring regulatory compliance
• Works towards meeting departmental and facility objectives. Works towards meeting quality objectives, as stated in quality system

Qualifications & Experience

• Relevant Science/Engineering Degree, or similar qualification preferred
• Proven experience in Quality Management Systems in a similar role within a medical device or a similar regulated environment
• Lead or Internal auditor qualified with proven audit experience
• Strong analytical and problem-solving skills
• Knowledge and experience of FDA regulations, MDSAP and MDR
• Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
• Excellent facilitation, coordination, prioritization, presentation and communication skills
• Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment
• Competence in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA department
• Ability to work across multiple facilities globally to ensure seamless compliance including when significant changes are being introduced