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Quality Systems Specialist

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Quality
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2400052V Requisition #

Careers that Change Lives


At Medtronic, we want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Apply now and be part of a highly successful and respective Quality Systems team in Medtronic Korea. We are a market leader in medical technology and a $400M business growing company by double-digit each year and is recently recognized as one of the greatest workplaces and happiest companies in South Korea!


A Day in the Life


Reporting to the Sr. Quality Systems Supervisor , the Quality Systems Specialist will handle the PMV operations to ensure the company is operating and meeting the established quality standard of medical devices across all business. This is a rare and incredible opportunity to enhance your skillset in supporting our market leading technology across a broad range of products.


Key Responsibilities:


Responsibilities may include the following and other duties may be assigned.

  • Handle Product Complaint
  • Handle Adverse Event Reporting, Oversee Adverse Event Reporting and Foreign Material reporting
  • Execute Field Corrective Action (FCA)
  • Collaborate with global complaint and FCA team for Enterprise quality strategy
  • Participate in harmonization and efficiency project for continuous improvement
  • Ensure Korea medical device regulation, ISO 13485 and Medtronic’s procedure
  • Prepare and support MFDS inspection

Must-Have

  • Completed Bachelor’s degree qualifications
  • Prior experience in a Quality Specialist role is essential with 2 to 4 years of relevant experience
  • Effective written and verbal communication skills in English and Korean languages
  • Strong ability to work well within a team and autonomously
  • Achievement oriented and ability to drive results with the highest quality standards
  • Computer skills (excellent knowledge of MS Office products)
  • High attention to detail and accuracy
  • Good prioritization and organizational skills
  • Excellent problem-solving skills


Nice to Haves

  • Degree in medical/ biological science or equivalent field
  • Industry experience is highly regarded (Medical Devices)


We Offer


In our 5th Tenet of our Mission, we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. Also, a competitive package is of course part of that. We offer a competitive salary and benefits package to all our employees:

  • Flexible working environment.
  • Annual Incentive Plan % depending on company results.
  • Pension scheme and group discount on healthcare insurances
  • Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract
  • Employee Assistance Program and Recognize! (our global recognition program)


About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.


Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services, and solutions companies, employing more than 86,000 people worldwide, serving physicians, hospitals and patients in over 155 countries.


Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your own career. Join us in our commitment to take healthcare Further, Together .

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