QA/RA Engineer

Description

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).