Senior QMRA Specialist

Improving human living conditions – that is our shared purpose at Eppendorf. With our high-quality, precise premium life science products – from pipette tips, dispensers and centrifuges to bioreactors and ultra-low temperature freezers – we help scientists around the world conduct research in the lab faster, more accurately and more efficiently.

I listen to truly understand.
I lead the way, even when the path ahead is not yet clear.
I stand by what I say.
I make progress visible and share what I learn.

If this resonates with you, you are exactly who we are looking for.
You will work with people who combine different perspectives and make new things possible. You contribute your ideas, ask questions, challenge the status quo – and you will find an environment that empowers you and helps you grow. Because we believe in people who want to shape the future. People like you.

How you can make an impact

As Senior QMRA Specialist, you will establish and continuously improve a standardized and manageable MultiSite Commercial Quality Management and Regulatory Affairs system for South Korea and the assigned export markets: Bangladesh, Bhutan, India, Maldives, Nepal, Sri Lanka, Hong Kong, Taiwan and Macao. You will reduce complexity across Sales and Service organizations while strengthening compliance, prevention, continuous improvement and customer satisfaction.

• You implement and maintain the effectiveness of the MultiSite Commercial QM System, ensuring compliance with applicable standards, local requirements and Corporate QM expectations across your assigned markets.
• As an initiative leader for end-to-end quality processes, you design, harmonize and standardize QM practices, tools and workflows in alignment with Corporate QM.
• You coordinate document control, change management, management reviews, audits, nonconformance management and CAPA activities, ensuring that actions are documented, followed up and completed effectively.
• As the market’s Management Representative, you represent the assigned markets within the local quality system and provide QM-related training, guidance and support to Sales and Service organizations.
• You act as the first contact for complaint management, reviewing complaint registrations, coordinating data cleaning and correction, supporting complaint classification training, and improving the quality and consistency of complaint data.
• You monitor post-market surveillance, adverse event reporting and field safety corrective actions, liaising with Eppendorf SE, Corporate Regulatory Affairs and R&D Regulatory Affairs whenever market-specific input or action is required.
• You proactively assess local regulatory requirements, registrations, certifications and standards, support regulatory inquiries, represent the markets towards authorities and notified bodies where applicable, and develop and monitor QM, PMS and RA KPIs for the assigned area and processes.

What sets you apart

• You hold a bachelor’s or master’s degree in quality management, regulatory affairs, life sciences, engineering or a related field, providing you with a strong foundation for QM and RA responsibilities.
• Several years of relevant experience enable you to manage quality management and regulatory affairs responsibilities independently, preferably in the medical device, life science or another regulated industry.
• You have a sound understanding of quality management standards and regulatory requirements, such as ISO 9001, ISO 13485 or comparable frameworks, and can apply them to commercial processes.
• Practical experience with audits, CAPA, nonconformances, change management, document control and management reviews allows you to establish effective and compliant processes.
• You have worked with complaint management, post-market surveillance, adverse event reporting or field safety corrective actions and understand the importance of accurate, timely and traceable data.
• Your analytical and conceptual skills enable you to assess regulatory requirements, identify their impact on the business, develop meaningful KPIs and translate complex information into clear recommendations.
• You communicate confidently in English, collaborate effectively with stakeholders across countries and functions, and approach changing requirements with a proactive, structured and solution-oriented mindset.

What we offer

• Purpose and impact. At Eppendorf, you work on solutions that help improve people’s lives around the world.
• We value your contribution. A fair, competitive salary and market‑appropriate benefits in line with local regulations.
• Flexible working. Depending on role requirements, a flexible working environment aligned with local policies that supports collaboration and work‑life balance.
• Time to recharge. Annual leave and public holiday arrangements in line with local law, plus additional leave types that support important life events.
• Health and wellbeing. Medical coverage and access to health and wellness support, complemented by local programmes such as health screening or wellness claims where available.
• Learning that moves you forward. With the Eppendorf Academy, digital learning platforms, language courses, workshops, community formats, coaching and development programs, you can grow continuously – both professionally and personally.

This is a fixed-term contract position created to cover an employee who is currently on childcare leave.

What matters to us

At Eppendorf, we believe that science thrives on curiosity – and on many different perspectives.

Our Eppendorf team is as diverse as the questions asked across the life sciences. Different backgrounds and ways of thinking help us develop better solutions for research.

Come as you are, bring what makes you unique – and help us shape what diversity can make possible in science.

Please note that we can only consider applications submitted via our online application system.

We look forward to getting to know you.

If you have any further questions, please contact:

MEOR HARITH ALWY MEOR SHAMSHUL ANUAR (contact person)

Meor.MHA@eppendorf.com.my

Eppendorf. Collaborate on new ideas.