At a Glance
- Tasks: Lead quality assurance for innovative medical devices, ensuring compliance and safety.
- Company: Dynamic medical device company focused on cutting-edge technology and quality.
- Benefits: Attractive salary, health benefits, flexible working options, and career development opportunities.
- Other info: Collaborative environment with opportunities to grow and innovate.
- Why this job: Make a real difference in healthcare by ensuring the highest quality standards.
- Qualifications: Degree in engineering or science with 3+ years in quality assurance.
The predicted salary is between 40000 - 50000 £ per year.
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 the 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 in a 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 inferential statistical techniques, sampling techniques, Measurement System Analysis (MSA), Design of Experiments (DoE) etc.; experience of using applicable software applications advantageous.
- Sound understanding of risk management techniques including Failure Modes & Effects Analysis (FMEA).
- Experience in application of common formal problem solving techniques.
Senior Quality Engineer in London employer: Gyrus Medical Limited
As a Senior Quality Engineer at our company, you will be part of a dynamic team dedicated to delivering safe and compliant medical devices. We pride ourselves on fostering a collaborative work culture that encourages innovation and continuous learning, providing ample opportunities for professional growth. Located in a vibrant area, we offer competitive benefits and a supportive environment that values your contributions and promotes work-life balance.
