Document Control and QARA Executive (MEDICAL DEVICE)

Company Overview / Employee Value Proposition

Merlin MD was founded by experienced executives and engineers from top-tier medical device companies like Boston Scientific, Guidant, and Micrus. Incorporated in Singapore on 1st July 2002, Merlin MD is presently developing innovative, life-saving and life-enhancing devices for the treatment of cerebral aneurysms. Its technology platform, however, is applicable to multiple clinical indications. Merlin MD is located in Singapore to take advantage of its precision engineering capabilities, healthcare and business infrastructures and competitive cost environment.

Job Summary

As a QARA professional at Merlin MD, you will lead the execution and continuous improvement of the Quality Management System and quality assurance activities to ensure regulatory compliance and support product excellence. You will collaborate across functions and communicate project status to executive leadership, driving quality initiatives that enable business growth and innovation.

Responsibilities

• Sustain and actively manage the Quality Management System by conducting Management Reviews, Internal Audits, Document Control, Product Release, and Training to ensure compliance and operational excellence
• Develop, verify, and implement Standard Operating Procedures aligned with company needs and regulatory requirements to maintain quality standards
• Formulate and recommend quality assurance strategies that drive continual improvement in line with organizational objectives
• Monitor and interpret external standards including ISO, IEC, European harmonized standards, FDA policies, industry journals, and national/international regulatory requirements to ensure ongoing compliance
• Implement and maintain management system compliance with international quality standards and regulatory frameworks such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820
• Interface with inspectors and Notified Body auditors during inspections, providing timely and accurate post-inspection follow-up information
• Manage daily quality assurance activities, facilitating improvements to the quality system while ensuring adherence to applicable Quality System Regulations and ISO standards
• Coordinate and liaise with remote QARA and PRRC teams to ensure alignment and effective quality management
• Communicate project status regularly to executive staff to inform decision-making and strategic planning

• Ensure the documentation system complies with regulatory and ISO requirements by coordinating updates to the Master List for calibration programs, service reports, sterilization validation plans, and product/material codes
• Maintain Quality Management System records including DHF, DMR, DHR, and Technical Files to support regulatory compliance and audit readiness
• Oversee maintenance and calibration schedules for quality instruments and equipment to guarantee operational reliability

• Drive achievement of quality objectives by monitoring compliance with quality policies and identifying opportunities for process efficiency improvements
• Collaborate closely with cross-functional teams including Operations, Procurement, R&D, Engineering, and Regulatory to integrate quality considerations into all phases of product lifecycle
• Execute additional tasks or projects as assigned by senior management to support organizational goals

Required competencies and certifications

• Knowledge of Quality Management Systems and regulatory standards including ISO 13485 and US FDA 21 CFR part 820
• Understanding of MDR 2017/745 Medical Device Regulation requirements
• Proficiency in Microsoft Office applications (Word, PowerPoint, Excel)
• Strong communication skills to interpret and explain GMP processes and documentation clearly in both verbal and written forms
• Ability to work independently with minimal supervision while supporting administration, product development, manufacturing, and product release activities

Preferred competencies and qualifications

• Bachelor’s degree in life sciences, engineering, or equivalent; or Diploma in life sciences, engineering, or equivalent with 2 years of relevant experience
• CEQ/ISO Certification

Other Information

• Minimum 2 years of related experience in the medical device or related industry
• Work environment includes office settings and controlled production areas (Cleanroom)
• Applicants must not have medical conditions that prevent access to controlled production areas