Job Description

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