Our Client is a global technology group that strengthens its customers and society long-term through forward-looking innovations. They Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros.
They make products that save and improve the lives of people every day, all around the world.
Our client has an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.
- Ensure all customer requirements are identified and clearly documented in Cambus Medical manufacturing documentation. This documentation includes CHRs, Work Instructions, Visual Standards, Purchasing Specifications, FMEAs etc.
- Document manufacturing procedures, CHRs, purchasing specifications, visual standards etc. Review and approve all updates to same.
- Investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the Cambus Medical CAPA system.
- Assess all product and manufacturing related changes, deviations and reworks, for their impact on validations, product quality and the customer.
- Review, control and disposition non-conforming product in accordance with the Cambus Medical NCR system.
- Make product dispositions as and when required. Update documentation such as specifications and visual standards to better define the quality characteristic being dispositioned.
- Prepare process data such as yield, output rates, No. of NCRs etc. and use this data to identify opportunities for improvement. Implement improvements on an ongoing basis.
- Perform internal audits as per agreed schedule and assist with preparations for external audits.
- Write validation protocols, reports and test reports as required.
- Perform First Article Inspections as required.
- Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
- Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
- Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
- Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.
- To take on other duties which the Company may assign you from time to time. These other duties will be agreed with Management prior to any assignment.
- Degree / Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry.
- A minimum of 3 years experience in a similar role.
- Excellent attention to detail.
- Ability to use problem solving tools (A3, PDCA, 5 Whys, Fishbone etc.)
- Good communication skills both verbal and written.
- A positive attitude in dealing with people.
- Experience working with Data Analysis Software (i.e. MiniTab) an advantage.
- Understanding of lean principles. Lean green belt an advantage.
- Ability to learn and adapt to various situations.
For further information on this role please contact Michael Marvin on 0864409255 / firstname.lastname@example.org
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