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.

Your Challenges

Responsibilities:

• Acts as the first point of contact in the region for all Commercial QM/RA topics, requests, and escalations.

•  Supports, guides, and coordinates the requests coming to the Commercial QM/RA team in APC.

•  Supports the team in building and maintaining QM/RA capability and in delivering quality management strategies and business results.

•  Provides functional guidance for the Commercial QM/RA team in the region.

•  Drives the implementation, harmonization, and continuous improvement of the Commercial QM System and QM/RA processes across Sales and Service organizations in Market Region APC.

•  Interfaces closely with Corporate QM, Corporate RA, R&D RA, Sales & Service organizations, and regulatory authorities.

• Builds QM/RA capability within the Market Region APC and leads QM/RA activities to create and deliver quality management strategies and business results.

• Drives the implementation and improvement of a Commercial QM System (ISO 9001, ISO 13485, ISO/IEC 17025) for the Market Region APC.

• Leads initiatives that impact QM/RA strategy or organizational structure; oversees implementation within the agreed framework (time, budget, quality) and manages these initiatives by monitoring KPI performance.

• Drives harmonization and standardization of quality processes, reducing complexity and duplication of activities across Sales and Service organizations.

• Leads the development, implementation, and improvement of state-of-the-art QM practices and tools.

• Liaises with Corporate QM to align and harmonize end-to-end quality processes Eppendorf-wide.

• Acts as first contact partner for the CRM complaint process for the Sales and Service organization in the region.

• Liaises with Eppendorf SE in case of adverse event reporting and Field Safety Corrective Actions.

• Applies RA knowledge and anticipates potential consequences for Eppendorf.

• Liaises with Corporate RA and R&D RA to identify market requirements for submissions in APC.

• Conducts local submissions in the region.

•  Leads the development, roll-out, and monitoring of QM, PMS, and RA KPIs.

• Ensures correctness of complaint data entry for the Sales and Service organization.

• Prepares, organizes, and supports audits by notified bodies and regulatory authorities.

• Monitors local product registrations, adverse event reporting, and Field Safety Corrective Actions.

Tasks:

• Initiate and support the QM/RA transformation process (behavior, mindset) by being a role model.

• Motivate and support cross-functional and intercultural teams and proactively provide functional leadership in QM/RA definition and deployment with focus on prevention, continuous improvement, and customer satisfaction.

• Identify challenges and improvement opportunities within the commercial organization for the Market Region APC.

• Ensure alignment of quality development process results with the strategic goals of Eppendorf SE.

• Contribute to the development and expansion of compliance and RA expertise within the QMRA team in Market Region APC (through coaching, sharing best practices, and subject-matter guidance).

• Implement and maintain state-of-the-art quality management practices.

• Identify applicable international and national standards and regulatory frameworks within the defined area of competence (countries, regulations) and interpret them to support internal and external stakeholders.

• Ensure correctness of complaint data entry for the Sales and Service organization.

• Prepare, organize, and support audits by notified bodies and regulatory authorities.

• Monitor local product registrations, adverse event reporting, and Field Safety Corrective Actions.

• Build and maintain QM, PMS, and RA KPIs within the defined area of responsibility and coach colleagues on their application and evaluation.

Your Expertise

• Minimum 5 years of Quality Management experience in Life Science industry or Medical Device industry

• Deep knowledge in Q-Systems ISO 9001 and 17025

• Degree in engineering in natural sciences or comparable technical (evtl. or Business) education

• Deep knowledge in Regulatory Affairs and Submissions wthin APC Region

• Excellent English language and communication skills,

• Additional language skills desirable (ideally Japanese, Korean,

• Comprehensive Quality knowledge within a Sales and Service

• Organization, e.g., guidelines, policies, principles, and requirements of applicable product laws/standards and APC

• Regulatory submission requirements

• Strong intercultural competence and experience in working with Asian and European/Western organizations

• Experience in cross functional working in a matrix organization

• Strong Project Management experience

Your benefits at Eppendorf:

• We truly appreciate our employees and their performance

• We offer a wide range of learning and development opportunities to allow you to deepen your technical knowledge and for continuous growth

• By working with us, you will make a meaningful contribution to improving human living conditions

• Attractive salary, employee benefits and performance bonus

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:

Chui Ting Pan (contact person)

Pan.C@eppendorf.com.my

Eppendorf. Collaborate on new ideas.