A highly innovative medical device manufacturer is actively looking for an experienced Quality Engineer to join their team on a contract basis. 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.
Roles & Responsibilities
- Perform vendor quality engineering activities, supporting the introduction of portfolio of injection moulded components used in production of electrosurgical medical devices.
- Ensure continuity of supply chain of high-quality conforming product meeting customers’ expectations
- Liaise with external injection moulding suppliers, ensuing timely documented execution of process validation and qualification activities in accordance with documented procedures and project plan
- Support suppliers; metrology, measurement system analysis, capability analysis and process validation activities including any necessary problem solving
- Review and approval of suppliers submitted approval documentation
- Compilation of information packs, regarding qualification activities, for external customers
- Update of company ERP and documentation systems with outcomes of approval activities
- Support other team members to optimise the effectiveness of quality engineering work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of GDP and GMP.
Skills & Experience
- HND equivalent in engineering, science, or technology discipline.
- Ability to interpret technical standards, technical drawings, and specifications
- Good understanding of metrology and other measurement practices
- Excellent report writing and presentation skills, good verbal communication skills.
- Experience in a range of statistical techniques including sampling techniques, Measurement System Analysis (MSA), capability analysis 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
If this sounds like the ideal role for you then please, apply within. Alternatively, give me a call on 02920 252 500 or send an email to h.morgan@intapeople.com