Senior QMRA Specialist

Market: South Korea, India subcontinent export market (Bangladesh, Bhutan, Nepal, Sri Lanka, Maldives), Hong Kong, Taiwan, Macao

Implement 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 growth
• Drive continuous improvement and deployment
• Focus on prevention action and customer satisfaction

Manage the design of end-to-end quality processes and tools to achieve highest customer satisfaction

Drive process harmonization and standardization within your market in alignment with Corporate QM

Be Management Representative for your market (according to local QM System)

Be first contact partner for the complaint management process for your market

Ensure correctness of complaint data entry for your market

Liase with Eppendorf SE in case of adverse event reporting and field safety corrective action

Overview and support all RA aspects as needed, incl. required registrations and certifications

Gather, analyze, assess, and communicate regulatory requirements and be internal and external contact point for market-related regulatory inquiries for your market

Liase with Corporate RA and R&D RA to identify market requirements and for submission in your market

Lead development and roll out of QM, PMS, and RA KPIs for area and processes of responsibility

Implement and maintain the effectiveness of the MultiSite Commercial QM System and ensure compliance with applicable standards for your market

Define, design, and utilize QM practices and tools

Implement and improve quality processes in alignment with Corporate QM

Design end-to-end processes as iniative leader

Organize and conduct document control, change management, management review, audit, nonconformance, and CAPA management

Provide QM related trainings within your market

Represent the your market as Management Representative

Communication and first contact partner for the complaint management process

Review uniformity of complaint registrations, incl. data cleaning and correction (Quality Review)

Conduct with complaint classification trainings to support training, mentoring, and continuous improvment

Monitor local adverse event reporting, and field safety corrective action

Represent your market torwards notified bodies and regulatory authorities

Proactively screen for new and relevant local regulatory requirements and standards for markets managed

Assess local regulatory requirements and provide information for Eppendorf impact

Liase with Corporate RA and R&D RA to identify market requirements for submission

Process QM/RA realted customer inquiries

Build KPIs and monitor QM, PMS, and RA KPIs, thereby collect data and provide reports

Support other QMRA colleagues in the region as required

• Quality 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.

• 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

Note: This recruitment is for a fixed-term leave replacement; the contract term is 17 months, with the possibility of renewal.