Your responsibilities will include:
- Review and approve product and process documentation throughout entire product lifecycle to ensure compliant, effective and suitably robust design solutions are fully documented
- 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
- Support legal manufacturers documentation requirements and technical enquiries to demonstrate company's state of the art regulatory solutions for applicable markets
- 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 the application of problem solving tools, to achieve documented resolution of technical issues affecting the product or process
- Apply statistical analysis procedures to product and process data during design, verification, validation and post launch to provide objective, data based analysis and conclusions
What we need from YOU:
- 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.
- Consistently hold people to account by making expectations explicit and regularly reviewing performance
- Motivate others through leading by example and creating an expectation that our colleagues do the same
- Provide both timely positive and negative feedback
- Understand our customers needs and deliver on our agreed commitments managing both risk and value to provide an optimum solution
- Communicate clear goals, objectives, consequences and timeframes for everyone
- Develop right first time approach to everything
- Foster respect, openness, collaboration and trust
- Empower and equip our people to take responsibility
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.