The Quality Technician will be working in the manufacturing area providing real time QA Support to the Production Line. This will include the implementation of process controls, CAPA systems, and day to day problem solving. This person will also be required to work within a team structure to manage the production lines.
- Provide hands on line support to the catheter and balloon production lines acting as a key member of the Line support team
- Work with the senior QE to actively implement Quality systems and standards.
- Ensure effective and efficient line handover from Day-Mid shift.
- Direct Involvement in continuous improvement projects and initiatives
- Maintenance of quality metrics and reporting systems Preparation of Quality reports for Quality meetings and management reviews
- Provide support to the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements
- Acts as an effective team member in supporting quality disciplines, decisions and practices.
- Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
- Ensure regulatory compliance to GMP for all medical device regulatory agencies
- Identify process & changes in procedures and standards to facilitate work efficiency and maintain quality.
- Reporting Functional area Quality Metrics
- Conduct internal quality audits to ISO and GMP requirements
- Initiating and completing non conformance reports & investigations.
- Good interaction and communication skills across functions.
- Min 2 year industry experience in a medical device manufacturing environment and within a QA Role.
- Relevant qualification in a Science/ Engineering/Quality Degree background and relevant industry experience
- Experience within a hands on line support type role is highly desirable.
- Good understanding of problem solving methodologies is required.
- Excellent Computer Skills (word, excel, PowerPoint and Access)
- Experience of working in a team and with cross functional teams.
- Flexible, highly motivated individual with a can-do attitude.