What you'll do
* The Quality Technician will perform an active role in further development and continuous improvement of the Quality Management system.
* Responsible for review of cleanroom environmental monitoring data and supporting improvement initiatives.
* Support and lead corrective action activities related to manufacturing processes and systems per the Non-Conformance/CAPA system.
* Offer quality guidance to a team of Product builders and Design Engineering teams in support of the day-to-day manufacturing operations.
* Responsibility for production GMP standards and compliance.
* Establish inspection standards and test methods including Validation activities.
* Prepare and update manufacturing 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.
* Maintain relevant documentation to comply with quality standards and customer requirements. Support Operations area projects and initiatives i.e. 5S, data analysis, problem solving tools, etc. Review of documentation, (i.e. DHRs, RI Records, validation records).
* Support compiling and reporting of weekly Quality Metrics.
* Other tasks as directed by the functional area Quality Manager in line with company goals and objectives.
What we're looking for
* Diploma qualification in Quality or a related discipline or significant relevant experience in a Quality Assurance role within the Medical Device Industry.
* Minimum of 2 years' industry experience in an ISO regulated environment.
* Hands-on experience with Catheter products is an advantage.
* A positive attitude in dealing with people.
* Clear understanding of medical device quality systems and requirements.
* Experience in product inspection techniques.
* Knowledge of root cause analytical and problem-solving skills.
* Knowledge of FDA and ISO Quality systems for Medical device companies desirable. Excellent written and oral communication skills essential.
Why Join ICS Medical Devices?
At ICS, we believe our people are the key to our success. We provide an environment where curiosity, innovation, and growth are encouraged — and where you'll have the opportunity to make a real impact in the medical device industry.
If you're driven, eager to learn, and ready to grow your career in a fast-paced and supportive environment, we'd love to hear from you.
Our Benefits
* Bike to work scheme
* Company events
* Company pension
* Employee assistance program
* On-site parking
* Private medical insurance
* Sick pay