A highly innovative medical device manufacturer is actively looking for an experienced Quality Engineer to join their team. They are genuinely revolutionising certain applications within their field and the successful candidate will be working on high tech, innovative products which will have a huge impact on people’s lives.
The successful Quality Engineer will be responsible performing quality engineering activities to support safe, efficacious and compliant development and sustainment of the organisation’s medical device designs and manufacturing processes.
Duties & Responsibilities
- 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.
Skills & Experience
- HND or equivalent 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.