PRINCIPAL ACCOUNTABILITIES
Establish, implement and promote; quality planning, design control, process control, verification and validation activities to aid delivery of efficient designs and processes providing 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 process is effective and robust in 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 and guide others in application of, industry standard statistical techniques to product and process including measurement system analysis, capability assessment, statistical monitoring and control, hypothesis testing, sampling, sample size determination and screening, factorial and response surface modelling; Design of Experiments so as to provide objective, data-based analysis and conclusions.
Provide and manage the application of problem-solving tools, to achieve documented resolution of technical issues affecting the product or process
Education / Qualifications
Graduate or equivalent calibre in engineering, science or technology discipline
Behaviours/Skills/Experience
Preferably minimum of three years 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
Strong understanding 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.
Sound understanding of risk management techniques including Failure Modes & Effects Analysis (FMEA).
Experience in application of common formal problem solving techniques.
