Terumo Aortic are currently looking to recruit a Senior Quality Engineer (complaints) to join our team. This role will provide Quality Engineering support to the complaints team including investigation and root cause analysis; review and analysis of returned complaint samples; complaint trend analysis and complaint reportability decisions. This is a fantastic opportunity to join a business where you can truly make a difference and enjoy career development.

The main responsibilities of the role are;

• Maintain all aspects of the complaints processes, ensuring compliant procedures and methods are in place for all related activities.
• Provide consultation and guidance on complaints investigation, impact assessments, risk assessments, and ensure implementation of good complaints practices.
• Provide support and resource to other functional areas to assist with complaints investigations and resolutions.
• Create, review, and Approve complaints and decision reports within stipulated time frames.
• Work collaboratively with other functional areas to effectively investigate and resolve complaint sourced product and process quality issues, deploying appropriate tools to assist complaints decision and risk assessment.
• Generate and maintain trending data for the complaints processes and publish as part of QMS KPI dashboard.
• Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers.
• Support the complaints Review Board, performing data analysis, creating updated presentation materials, hosting the meeting and creating meeting minutes.
• Support the development of complaints team members to deliver effective and compliant process, including the timely closure of quality events, NCRs, CAPAs and associated actions owned by Complaints Team.
• Provide input to dFMEAs and pFMEAs as appropriate
• Develop and deliver training materials for complaints team
• Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business.
• Support internal and external audits as SME for complaints.  
• Own any complaints or vigilance related Gap Analysis and ensure that procedures are reviewed and updated to meet the regulatory requirements.
• Identifying opportunities to improve processes through use of Lean Methodology or operational excellence principle and tools.

The successful candidate will possess;

• Relevant Science/Engineering Degree or equivalent.
• Clinical background e.g. radiographer or cardiovascular clinical knowledge is highly desirable
• Six Sigma qualification preferred.
• Proven experience in Quality Management 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, such as  ISO13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745).
• Knowledge and understanding of applicable regulations, especially in relation to MDR/MIR reporting.
• Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment.
• Must be able to work cross-functionally and be able to lead teams Complaints quality Engineers and Investigators to complete appropriate complaints documentation for products and processes.