Manager, Quality Management Systems

At Genesis MedTech, our quest is to make quality healthcare accessible for everyone. We believe each of us can make a positive impact at work. Together we explore ideas, innovate new solutions and make great things happen. Our culture is built on collaboration and a shared commitment to make an impact on the lives of our patients.

Position Overview

As part of our international quality team, you will be at the forefront of upholding the highest standards of quality for our innovative medical devices. With a strong understanding of industry regulations and a commitment to excellence, you will play a key role in driving the success of our commercial operations globally.

The Manager, Quality Management Systems (QMS) is responsible for the implementation, maintenance, and continuous improvement of the company's Quality Management System.

This role ensures full compliance with Singapore regulatory requirements and alignment with global quality standards. Reporting to the Head of Quality, International, the role supports the deployment of quality systems, processes, and tools across the product lifecycle within the Surgical Business, spanning multiple international markets.

Key Responsibilities

Quality Systems & Compliance

• Develop, implement and maintain core Quality Systems, including CAPA, Nonconformance, Change Control, Document Management, GMP Training, Quality Agreements, and Complaint Handling.
• Ensure QMS documentation and records are accurate, controlled, and audit-ready.
• Lead and manage implementation of QMS-related digital systems/tools and subsequent maintenance.
• Lead site Management Review and Quality Metrics programs to monitor compliance and drive performance improvements.
• Plan and conduct internal audits, supplier audits, and support external and regulatory inspections.
• Ensure timely implementation of regulatory updates and industry best practices.
• Maintain effective working relationships with regulatory authorities and external auditors.
• Promote a strong quality culture and continuous improvement mindset across the organization.

Training & Capability Building

• Oversee QMS training programs and ensure compliance with training requirements.
• Develop and deliver training to strengthen organizational understanding of quality and regulatory standards.

International Responsibilities

• Translate QMS strategy into execution across international markets, ensuring consistent and compliant implementation of processes, systems, and standards in collaboration with manufacturers and country/regional quality teams.
• Support global product quality surveillance activities, including periodic product-specific data reviews.

Requirements

Qualifications & Experience

• Bachelor's degree in Engineering, Science, or a related field
• Minimum 6 years of experience in medical devices, MedTech, or other regulated industries
• Strong working knowledge of ISO 13485, GDPMDS (SS620), MDSAP, EU MDR (2017/745), FDA 21 CFR Part 820, GMP / GDP / GLP
• Experience in a commercial / distribution environment is preferred
• Experience working across international markets, particularly in APAC, LATAM, and Europe, with an understanding of regional regulatory and operational requirements
• Proven experience supporting regulatory inspections and audits

Skills & Competencies

• Strong understanding of QMS and regulatory frameworks
• Solid problem-solving skills with experience in investigations and CAPA
• Effective communication and stakeholder management skills
• Ability to manage multiple priorities independently
• Detail-oriented with a continuous improvement mindset
• Strong collaboration and teamwork capabilities
• High integrity and commitment to compliance
• Proficiency in English

About Genesis MedTech

WE MAKE BETTER HEALTHCARE HAPPEN.

This is our quest: to make quality healthcare more affordable and accessible.

Headquartered in Singapore, Genesis MedTech shares a bold new world of value-based healthcare across surgical, cardiology and vascular interventional specialities.

With an open platform that brings the best of medtech together from every corner of the globe, we disrupt the inefficiencies and fragmentation that keep quality healthcare out of reach for many. Genesis MedTech aims to become the most scalable, efficient and transparent business platform for the medtech industry. At Genesis MedTech, we are also actively growing our product portfolio through R&D and innovation, acquisitions, as well as partnerships with strategic startups.

Website: https://www.genesismedtech.com/