Senior QMRA Specialist

Your challengesMarket: South Korea, India subcontinent export market (Bangladesh, Bhutan, Nepal, Sri Lanka, Maldives), Hong Kong, Taiwan, MacaoImplement and improve a standardized and manageable MultiSite Commercial QM System for your market which will reduce the complexity and duplication of activities across Sales and Service Organizations while building capabilities to:Ensure compliance to enable growthDrive continuous improvement and deploymentFocus on prevention action and customer satisfactionManage the design of end-to-end quality processes and tools to achieve highest customer satisfactionDrive process harmonization and standardization within your market in alignment with Corporate QMBe Management Representative for your market (according to local QM System)Be first contact partner for the complaint management process for your marketEnsure correctness of complaint data entry for your marketLiase with Eppendorf SE in case of adverse event reporting and field safety corrective actionOverview and support all RA aspects as needed, incl. required registrations and certificationsGather, analyze, assess, and communicate regulatory requirements and be internal and external contact point for market-related regulatory inquiries for your marketLiase with Corporate RA and R&D RA to identify market requirements and for submission in your marketLead development and roll out of QM, PMS, and RA KPIs for area and processes of responsibilityImplement and maintain the effectiveness of the MultiSite Commercial QM System and ensure compliance with applicable standards for your marketDefine, design, and utilize QM practices and toolsImplement and improve quality processes in alignment with Corporate QMDesign end-to-end processes as iniative leaderOrganize and conduct document control, change management, management review, audit, nonconformance, and CAPA managementProvide QM related trainings within your marketRepresent the your market as Management RepresentativeCommunication and first contact partner for the complaint management processReview uniformity of complaint registrations, incl. data cleaning and correction (Quality Review)Conduct with complaint classification trainings to support training, mentoring, and continuous improvmentMonitor local adverse event reporting, and field safety corrective actionRepresent your market torwards notified bodies and regulatory authoritiesProactively screen for new and relevant local regulatory requirements and standards for markets managedAssess local regulatory requirements and provide information for Eppendorf impactLiase with Corporate RA and R&D RA to identify market requirements for submissionProcess QM/RA realted customer inquiriesBuild KPIs and monitor QM, PMS, and RA KPIs, thereby collect data and provide reportsSupport Other QMRA Colleagues In The Region As RequiredYour expertiseQuality Systems Expertise: Deep knowledge in Q-Systems, specifically ISO 9001, ISO 17025, and ISO 13485.Regulatory Knowledge: Extensive experience in regulatory submission processes in Korea.Industry Experience: At least 3 years of experience in the Life Science or Medical Device industry.Educational Background: Degree in natural sciences or a comparable scientific or technical education.Skills & Competencies:Excellent English language and communication skills; additional language skills related to relevant markets are desirable.Intercultural Competence: Strong intercultural competence with experience working with Asian and European/Western organizations.Collaborative Skills: Proven ability to work cross-functionally in a matrix organization.Communication: Exceptional communication skills, capable of leading and influencing at all organizational levels.Your benefits at Eppendorf:We truly appreciate our employees and their performanceWe offer a wide range of learning and development opportunities to allow you to deepen your technical knowledge and for continuous growthBy working with us, you will make a meaningful contribution to improving human living conditionsAttractive salary, employee benefits and performance bonusNote: This recruitment is for a fixed-term leave replacement; the contract term is 17 months, with the possibility of renewal.