Senior Quality Systems Engineer Role
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As a key member of our team, you will play a pivotal role in implementing and maintaining our company's quality management system. This is an exciting opportunity to work collaboratively in a state-of-the-art facility.
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Responsibilities:
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* Ensure that quality systems adhere to relevant regulations.
* Maintain and continuously improve the quality management systems.
* Coordinate CAPA, Complaints & Temporary Authorization processes.
* Review and approve Non-conformance, CAPA and Complaint investigation reports.
* Manage the audit schedule and coordinate internal and external audits.
* Collect and analyze quality systems data for timely generation of Monthly Reports.
* Present data on quality system performance.
* Generate quality systems data for Post Market Surveillance purposes.
* Provide quality review on documentation including procedures, specifications, investigations, and other Quality Management System documentation.
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Requirements:
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* Educated at a minimum to a diploma level in an engineering, science, or quality assurance discipline.
* Training/qualification in quality systems, complaints, and CAPA is highly desirable.
* A minimum of five years' relevant experience in the medical device industry.
* Familiarity with ISO 13485, ISO 14971, Medical Device Regulation 2017/745 and FDA QSRs is required.
* Experience in managing quality systems activities, particularly complaints and CAPA, is desirable.