We seek strong, enthausitic and ambiteous quality technician who will help drive quality here at ICS Medical Devices.
Reporting to the Quality Manager, the Quality technician is a member of the Quality group supporting design and manufacturing activities. This challenging position will require an ability to work within a collaborative environment, pursuing continuous improvement and ensuring compliance to both internal and customers Quality Systems. The person is responsible for policies and related to product compliance, environmental monitoring, quality control governing materials, product and processes, as well as failure analysis, root cause, corrective action and customer communication.
- The Quality technician will perform an active role in further development and continuous improvement of the Quality Management system.
- Identifying any potential trends during failure analysis and initiating improvement initiatives relating to Cleanroom Environmental Monitoring.
- Lead corrective action activities related to manufacturing processes and systems and the NC/CAPA system.
- Offer quality guidance to a team of Product builders and Design Engineering teams in support of the day-to-day manufacturing operations.
- Develop strong links with customer organisation’s and other project stakeholders.
- Responsibility for production GMP standards and compliance.
- Establish inspection standards and test methods including Validation activities.
- Prepare and update Operations procedures and associated documentation.
- Support customer audits and surveillance/accreditation audits.
- Conduct audits of the Manufacturing Operation and the Quality System ensuring compliance with ISO13485.
- Establish and maintain risk management principles and methods throughout the product
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem-solving tools, etc.
- A minimum of a certificate in a Quality/Science or related discipline.
- Experience within a GMP regulated environmental as Quality technician.
- 3+ years industry experience in an ISO regulated environment.
- Hands-on experience with Catheter products is an advantage.
- Knowledge of Environmental Monitoring programmes is an advantage.
- Excellent written and oral communication skills essential.