Permanent
Quality Engineer
Inchinnan

Quality Engineer - Risk

Ref: 124| Posted: 30th Jan 2023

Terumo Aortic requires an experienced Quality Engineer, the successful individual will be responsible for supporting the development and management of the Risk Management & Post-Market Surveillance Processes at Terumo Aortic and to ensure that all related processes and procedures meet the requirements of all applicable regulatory standards. This is a fantastic opportunity for someone to further develop their career whilst adding real value.


 

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

  • 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 Medical Device Directive and 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