At TÜV SÜD we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD.

Your Tasks

• Manage conformity assessment for customers’ certificates according to the requirements of ISO 13485:2016, MDD/MDR/IVDD/IVDR, and MDSAP in the field of active medical devices
• Perform onsite audits at manufacturers’ premises domestic or oversea by evaluating their Quality Management Systems in accordance with the requirements
• Perform all related tasks, such as scheduling, planning, reviewing corrective actions, and preparing reports and audit documentation for submission to the certification committee of the Notified Body
• Perform evaluations of regulatory submissions including change notification documentation assessments (EU Directives / EU Regulations)
• Make prompt decisions with objective and impartial matter based on the objective facts, and reaching agreement with the customers
• Keep learning the updated medical device regulation as well as expanding the experience/ authorization additional area of medical devices and its associated standards in English to add the value to the customers

Your Qualifications

• Bachelor’s degree or above / Electrical Engineering, Physics, Medical Engineering, Information Technology, Computer Science, Software or Relevant Engineering·Science Discipline
• Minimum 4 years of relevant experience in testing medical devices, design and development activities, process validation, application of process technology, and service and maintenance in the medical device industry
• At least 2 years’ experience in Quality Management Systems environment (e.g. manufacturing, quality control, or research)
• Clear and articulate presentation ability with excellent communication skills even in challenging situations
• Fluency in Korean and English / Good communication and writing skills in English
• Well organized, self-motivated and being able to work with minimal supervision

What We Offer

• Flexible working hours
• Wellness benefit
• Meal allowance support
• 2days of annual leave for 1month of perfect attendance
• Training & growth opportunities

Additional Information

• Contract type : Permanent
• Please submit below required documents as PDF file.
• Korean resume
• English resume

You don’t meet every single requirement? No problem — we encourage you to apply if this role excites you. We welcome applications from people of all backgrounds, experiences, and perspectives.

At TÜV SÜD, we have employees from more than 100 different countries collaborating together. People of different backgrounds, skills, and pursuing different life goals. Our strength comes from these countless and varied perspectives.

We are committed to be an inclusive and diverse workplace by welcoming people of all backgrounds. We want Diversity & Inclusion (D&I) to be a foundation of our company and create an environment where all our employees can trust they will be treated with respect, regardless of gender, nationality, ethnic background, faith, beliefs, disabilities, age, sexual orientation, or identity. As such, our employees are expected to behave at all times in a manner consistent with TÜV SÜD Code of Ethics and Company values.

We firmly believe embedding D&I in the heart of what we do will inherently contribute to the success of TÜV SÜD. Click here to find out more about Diversity at TÜV SÜD.