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.
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
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