An excellent opportunity to work for a leading medical technology company you will
- Execute procedures regarding quality planning, design control, process control, verification and validation to aid delivery of efficient designs and processes which provide safe, effective and compliant medical devices
- Review and approve product and process documentation throughout entire product lifecycle to ensure compliant, effective and suitably robust design solutions are fully documented
- Ensure risk management procedures are fully applied identifying product and process risks and that risk mitigations are implemented so as to ensure safe and compliant medical devices
- Support legal manufacturers documentation requirements and technical enquiries to demonstrate company’s state of the art regulatory solutions for applicable markets
- Apply statistical analysis procedures to product and process data during design, verification, validation and post launch to provide objective, data based analysis and conclusions
- Support the application of problem solving tools, to achieve documented resolution of technical issues affecting the product or process.
HND equivalent calibre in engineering, science or technology discipline
- Preferably minimum of one year in a quality related field, beneficial if within a Medical Device design environment or equivalent regulatory controlled environment
- Experience of quickly evolving environment with cross functional team working
- Ability to interpret; technical standards, technical drawings and specifications with a good understanding of metrology and other measurement considerations
- Excellent report writing and presentation skills, good verbal communication skills
- Experience of a range inferential statistical techniques, sampling techniques, Measurement System Analysis (MSA), Design of Experiments (DoE) etc.; experience of using applicable s/w applications advantageous
- Experience of risk management techniques including Failure Modes & Effects Analysis (FMEA).
- Exposure to common formal problem solving techniques.