Quality Engineer

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 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 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 7/ 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 ISO

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