Job Title: Senior Quality Systems Engineer
We are seeking a skilled professional to spearhead the implementation and maintenance of our company's Quality Management System. This is a pivotal role in ensuring compliance with Medical Device Directives and Regulations.
About the Role
* Maintain and continuously improve quality management systems.
* Coordinate CAPA, Complaints & Temporary Authorization processes.
* Review and approve non-conformance reports.
* Manage audit schedules and coordinate internal and external audits.
* Collect and analyze quality system data.
* Prepare and present quality system performance reports.
* Act as primary contact for quality oversight.
Requirements
* Degree level in Engineering, Science or Quality Assurance discipline.
* Training/qualification in Quality Systems desirable.
* Minimum five years' experience in medical device industry.
* Familiarity with ISO13485, ISO14971 and FDA QSRs required.