Commercial Quality Manager

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.

You will lead post-market quality activities for Singapore and selected international markets, including the establishment and execution of an effective Customer Complaint Handling Process. You will also set up and maintain a robust Quality Management System (QMS) to support commercial operations, covering importation, preservation, and distribution of medical devices across Singapore and Southeast Asia markets.

As the Commercial Quality Manager, you will also support the Head of Quality in interfacing with competent authorities on post-market vigilance activities, including Field Safety Corrective Actions, and manage customer communications on quality matters. This role is integral to building a strong customer quality engagement framework, process and ensuring continuous compliance and improvement.

Key Responsibilities

• Drive product quality and compliance, partnering with Commercial team, Field Technical Services, Manufacturer's Technical and Quality team to ensure customer excellence.
• Ensure proper escalation of major and critical product/quality defects and relevant customer complaints are handled effectively in a timely manner.
• Coordinate and promptly perform any FSCA decision-making process and meet the timeline prescribed for reportable Adverse Events.
• Establish and maintain the Quality Management System to support the commercial activities and associated Post Market Quality activities
• Responsible for managing and maintaining quality metrics for the customer quality activities, providing leadership updates in management reviews on projects and KPI's as necessary.
• Manage external 3PL in ensuring the warehousing, logistics and rendered services adhere to the Quality Requirements defined by Genesis Medtech/affiliated franchises/business partners.

Requirements

• Bachelor's degree in Engineering, Science, or a related field.
• Solid understanding of ISO 13485, GDPMDS SS 620, MDSAP, MDR 2017/745, FDA 21 CFR Part 820, GMP, GDP, and GLP.
• Minimum of 8 years experience in commercial and post-market quality within the medical device, MedTech, or other regulated industries.
• Field experience in Singapore is required; regional (Southeast Asia) experience is a strong plus.
• Hands-on experience managing NC/CAPA, product field actions, and customer complaints.
• Proficiency in English is required; proficiency in Chinese is an advantage for liaising with international stakeholders and reviewing bilingual quality documentation.
• Strong communication skills with the ability to build trusted relationships across functions and cultures.
• Collaborative problem solver with sound judgment and decision-making abilities.
• Highly organized with strong planning and prioritization skills.
• Thrives in a fast-paced medical device start-up environment; hands-on, proactive, and adaptable.

We do not accept any unsolicited referrals from any staffing or recruitment agencies for this role and shall therefore not be liable for any fees arising from any unsolicited referrals in respect of this role.

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/