QUALITY ASSURANCE & REGULATORY AFFAIRS ENGINEER

Medical Devices Manufacturing & Assembly

Location: Umm Al Quwain, United Arab Emirates

Employment Type: Full-Time | On-Site

About A Electronics Group

A Electronics Group is a UAE-based manufacturer and assembler of medical and electronic equipment operating under internationally recognized quality standards. The company is committed to delivering safe, reliable, and high-quality products through robust quality management systems, regulatory compliance, and continuous improvement.

The company operates a dedicated manufacturing and assembly facility in Umm Al Quwain and is expanding its activities in medical device manufacturing, assembly, testing, calibration, servicing, and technical support for regional and international markets.

Position Summary

We are seeking a highly experienced Quality Assurance & Regulatory Affairs Engineer to establish, maintain, and continuously improve the company’s Quality Management System (QMS) and ensure compliance with applicable regulatory and quality standards.

The selected candidate will play a key role in supporting manufacturing operations, supplier quality management, validation activities, regulatory compliance, product quality assurance, and continuous improvement initiatives.

This position is intended for professionals with proven experience in medical device manufacturing, medical equipment assembly, regulated industries, and quality system implementation.

Key Responsibilities

• Establish, maintain, and continuously improve the Quality Management System (QMS).

• Ensure compliance with ISO 13485, ISO 9001, GMP, CE requirements, and applicable regulatory standards.

• Develop, review, approve, and maintain quality documentation, including SOPs, Work Instructions, Quality Procedures, Forms, Records, and Quality Manuals.

• Manage incoming inspection, in-process inspection, final inspection, testing, and product release activities.

• Lead CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), deviation management, and Root Cause Analysis activities.

• Support supplier qualification, supplier audits, supplier performance evaluation, and supplier quality improvement programs.

• Participate in product and process validation activities, including IQ, OQ, and PQ protocols.

• Conduct internal audits and prepare the organization for external audits by certification bodies and regulatory authorities.

• Support CE technical documentation and regulatory compliance activities.

• Implement and maintain risk management processes in accordance with ISO 14971.

• Monitor quality indicators and prepare management reports and quality performance metrics.

• Support calibration management, equipment qualification, and environmental monitoring activities.

• Ensure effective document control and record retention systems.

• Collaborate closely with Production, Engineering, Service, Procurement, and Management teams.

• Participate in customer complaint investigations and post-market quality activities when required.

Mandatory Qualifications

• Bachelor’s Degree in Biomedical Engineering, Electrical Engineering, Electronics Engineering, Industrial Engineering, Quality Engineering, or a related discipline.

• Minimum 5 years of proven experience in Medical Device Manufacturing, Medical Equipment Assembly, Electronics Manufacturing, or another highly regulated industry.

• Demonstrated hands-on experience implementing and maintaining ISO 13485 Quality Management Systems.

• ISO 13485 Lead Auditor Certification (Mandatory).

• Strong practical experience with:

• CAPA
• NCR
• Internal Audits
• Supplier Qualification
• Root Cause Analysis
• Risk Management
• Validation Activities
• Quality Documentation Systems

• Practical experience with IQ, OQ, and PQ protocols.

• Strong understanding of CE regulatory requirements and medical device technical documentation.

• Experience preparing organizations for external audits and regulatory inspections.

• Excellent knowledge of quality control, inspection techniques, and quality assurance methodologies.

• Strong analytical, organizational, and problem-solving skills.

• Excellent communication and technical documentation skills in English.

Preferred Qualifications

• ISO 9001 Lead Auditor Certification.

• Training or certification in ISO 14971 Risk Management.

• Experience with Ultrasound Systems, Patient Monitoring Systems, ECG Devices, X-Ray Systems, MRI Components, CT Components, or related medical technologies.

• Experience with ERP systems and electronic document management systems.

Important Note

This position requires a hands-on professional capable of independently managing quality and regulatory activities within a medical device manufacturing environment. Candidates without relevant practical experience in regulated industries and medical device quality systems will not be considered.

What We Offer

• Opportunity to join a growing UAE-based medical technology manufacturer.

• Direct involvement in building and strengthening a world-class quality management system.

• Professional development and career growth opportunities.

• Exposure to international standards and regulatory requirements.

• Competitive salary package based on qualifications and experience.