Terumo Aortic are currently recruiting for a Quality Engineer. The successful candidate will be responsible for supporting the development and management of the Risk Management & Post-Market Surveillance Processes and ensuring that all related processes and procedures meet the requirements of all applicable regulatory standards. This is a fantastic opportunity to join a growing team.

Key duties;

• Provide consultation and advice on risk related subjects, supporting business objectives whilst ensuring regulatory compliance
• Support all risk processes and risk assessments
• Development of Terumo Aortic's risk management system, ensuring associated risk processes aligned with the requirements of ISO 14971
• Development and deployment of robust processes and procedures for effective assessment of design, process, post-market data and business risk
• Deployment of risk assessment tools/methods within Terumo Aortic
• Development and delivery of training programmes to educate Terumo Aortic employees on the correct use of product safety risk assessment and feasibility studies
• Development of a suite of risk assessment tools including Failure Mode and Effects Analysis (FMEA), and other appropriate tools to maintain an effective Risk Management process
• Development of a comprehensive programme to create and maintain appropriate risk files for all products and processes
• Development of cross-functional and collaborative relationships within the facility
• Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business
• Participate in facility Internal Audit programme
• Perform post-market surveillance reviews and co-ordinate any resulting actions (e.g. update of documentation, instigation of corrective action)
• Conduct in-depth investigations as required
• Preparation of risk documentation in a timely manner to support business objectives

Qualifications & Experience;

• Relevant Science/Engineering Degree
• Qualification or training experience in risk management, risk assessments or other comparable activity
• Extensive and proven experience in Quality Systems in a similar role within a medical device environment
• Solid experience in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
• Experience of EU Medical Devices Regulation 2017/745 and other related regulations, preferably for Class Ill devices
• Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
• Strong analytical and problem-solving skills
• Ability to work on own initiative
• Excellent facilitation, coordination, prioritisation, 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
• Must be able to work cross-functionally and be able to lead teams of R&D and Manufacturing Engineers to complete appropriate risk documentation for their products and processes
• Must be able to influence change with objective information and well-structured communications
• Must have working knowledge of the requirements of ISO14971