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We are a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. We are seeking a talented QA /RA Engineer to join our quality and regulatory team, playing a dual role that ensures our products meet the highest quality standards while navigating complex global regulatory requirements.
SCOPE & RESPONSIBILITIES
Quality Assurance Manage ECOs: conduct risk assessments, update relevant DMR documents and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks. Manage DCOs in the PLM system : write and update QA procedures to ensure compliance with quality standards and regulatory requirements. Manage NCR and CAPA processes: lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions. Manage QA production activities: provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality. Ensure timely resolution of quality issues: promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations. Participate in internal and external audits, such as FDA inspections and notified body audits based on ISO 13485, EU MDR, and MDSAP requirements. Supplier Quality Management: manage supplier qualification and performance monitoring, including SCAR management, and support supplier audits.
Regulatory Affairs Prepare, coordinate, track, and follow up on submissions for medical devices across various international markets. Prepare and manage EU MDR technical documentation submissions. Oversee CER, PMS, and PMCF activities, including customer complaints, vigilance, and recall. Participate in regulatory inspections and audits. Prepare regulatory assessments for design changes. Develop labeling according to applicable regulatory requirements. Evaluate and communicate regulatory impact of ECOs and design changes across QA and RA domains.