The successful candidate will be working in the manufacturing area providing real time Quality Assurance support to the production line. This will include the implementation of process controls, CAPA systems and day to day problem solving. Work within the Core Team structure to manage the production lines.
- Responsible for providing hands on line support to the catheter and balloon production lines acting as a key member of the Core line support team.
- Demonstrate the ability to work with the Core Teams, Line Leads and Engineering Support and the Senior Quality Engineer.
- Actively implement quality systems and standards.
- Responsible for ensuring effective & efficient line handover from day-mid-day shifts by providing good communications on line issues & quality items.
- Responsible for direct involvement & leading continuous improvement projects and initiatives.
- Responsible of the preparation & maintenance of quality metrics and reporting systems.
- Responsible for preparation of quality reports for presentation at quality meetings and management reviews.
- Responsible for provision of 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.
- Applies sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues and leading problem solving.
- Ensures regulatory compliance to GMP for all medical device regulatory agencies.
- Demonstrates the ability to identify process & changes in procedures and standards to facilitate work efficiency and maintain quality.
- Responsible for reporting on functional area quality metrics.
- Responsible for conducting internal quality audits to ISO and GMP requirements.
- Responsible for initiating and completing Non Conformance reports & investigations.
- Excellent interaction and communication skills across functions.
- Min 2 years industry experience in a medical device manufacturing /cleanroom environment in a QA Role.
- Science/ Engineering/Quality Degree and relevant experience (Level 7 min).
- Strong commitment to Quality, Safety, GMP & GDP.