Terumo Aortic are currently looking to recruit a Quality Engineer for our CAPA team, due to investment and growth the team are currently expanding and have an excellent opportunity for someone to grow and develop their career with a truly global organisation.
The main responsibilities of the role are;
- Maintain the management tools (trackers, electronic folders, etc) comprehensive and audit ready.
- Provide guidance and support for effective investigation and root cause analysis for new CAPAs, working collaboratively with other functional areas as appropriate
- Provide guidance and support for effective implementation of corrective/preventive actions from CAPA investigations
- Provide guidance and support for robust effectiveness measurement of CAPA actions
- Support development of solution verification tools to validate CAPA action plans
- Maintain the communication with the CAPA owners regarding time frames and progress updates.
- Working with other functional areas as appropriate, ensure appropriate containment actions are defined and communicated
- Generate and maintain trending data for the CAPA process and publish as part of QMS KPI dashboard Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers
- Provide data trending information and CAPA status updates to the CAPA Review Board
- In conjunction with the Risk Team, provide QE input to dFMEAs and pFMEAs, particularly with respect to CAPA data
- Work towards meeting departmental and facility objectives
- Participate in facility Internal Audit programme
- Development of cross-functional and collaborative relationships within the facility
- Creating new policies or procedures to improve efficiency in CAPA handling.
- Identifying opportunities to improve processes through training or other means.
The successful candidate will possess;
- Relevant science / engineering degree
- Six Sigma qualified – minimally Green Belt level desirable
- Knowledge and understanding of applicable regulations especially with regards to CAPA processes and Root Cause Analysis/Trend Analysis
- Class III medical device knowledge (desirable)
- Proven experience of working in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
- Working knowledge of Minitab or similar statistical tool
- Experience of FDA regulations
- Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
- Strong analytical and problem-solving skills, including appropriate use of statistical techniques
- Excellent facilitation, coordination, prioritising, and communication skills
- Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment