A highly skilled Senior Quality Systems Engineer is sought to play a key role in the implementation and maintenance of quality management systems at our state-of-the-art facility. The ideal candidate will have extensive experience in managing quality systems activities, particularly complaints and CAPA.
Key Responsibilities:
* Ensure compliance with relevant regulatory requirements
* Maintenance and continuous improvement of quality management systems
* Coordinate CAPA, complaints and temporary authorization processes
* Review and approve non-conformance, CAPA and complaint investigation reports
* Manage quality systems data collection and analysis
* Coordinate internal and external audits
The successful candidate will have a diploma level in engineering, science or quality assurance discipline and a minimum of five years' relevant experience in the medical device industry. Familiarity with ISO 13485, ISO 14971 and FDA QSRs is required. A highly desirable skillset includes training/qualification in quality systems, complaints and CAPA.
Requirements:
* Diploma level in engineering, science or quality assurance discipline
* Minimum of five years' relevant experience in the medical device industry
* Familiarity with ISO 13485, ISO 14971 and FDA QSRs
* Training/qualification in quality systems, complaints and CAPA