Job Summary:
We are seeking an experienced Senior Quality Systems Engineer to join our team. As a key member of our organization, you will be responsible for ensuring the quality management system is compliant with relevant regulations and industry standards.
Key Responsibilities:
* Evaluate and maintain the quality management system to ensure compliance with Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, and FDA Quality System Regulations.
* Coordinate CAPA, Complaints & Temporary Authorization processes to support owners in meeting required timelines.
* Review and approval of non-conformance, CAPA, and complaint investigation reports.
* Analyze quality systems data to facilitate timely generation of monthly reports.
* Prepare and present data to management on quality system performance.
* Generate quality systems data as required for post-market surveillance purposes.
* Provide quality oversight to other departments to ensure compliance and promote quality improvements.
* Review quality documentation, including procedures, specifications, investigations, and other quality management system documentation.
Requirements:
* Educated at a minimum to a diploma level in an engineering, science, or quality assurance discipline.
* Familiarity with ISO 13485, ISO 14971, Medical Device Regulation 2017/745, and FDA QSRs is required.
* A minimum of five years' relevant experience in the medical device industry is preferred.