QA/RA Engineer
Rapid Medical is 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.
Requirements
Education & Experience:
• Bachelor’s degree in Biomedical Engineering, Biotechnology, or a related engineering/science discipline.
• 4- 6 years of experience in a combined or individual QA/RA role within the medical device industry.
• Hands-on experience with ISO 13485, FDA QSR 820/QMS, EU MDR, and MDSAP requirements.
• Internal auditor certification – an advantage.
• Knowledge and practical experience in Priority ERP – an advantage.
Skills & Competencies:
• High-level proficiency in English – both written and spoken.
• Excellent teamwork ability and interpersonal skills.
• Service-oriented mindset with strong attention to detail.
• Ability to work in dynamic, multi-interfaced surroundings with both micro and macro vision.
• Strong time management skills; ability to manage priorities and work under pressure.
• Self-learning ability and proactive approach to problem solving.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).