Quality Systems Specialist

Medtronic UK

Competitive salary; short-term incentive via mip; ...
Onsite
Korea qms adherence to iso 13485
Kgmp onsite audit experience
Post market surveillance support
The role involves leading Quality Management System operations to ensure compliance with Korea medical device regulations and ISO 13485 standards

Job Summary

  • The role involves leading Quality Management System operations to ensure compliance with Korea medical device regulations and ISO 13485 standards.
  • Candidates will manage critical quality functions including internal audits, corrective actions, adverse event reporting, and distributor oversight.
  • Medtronic offers a competitive salary, flexible benefits package, and eligibility for the Medtronic Incentive Plan (MIP) to support career growth.

Matching Summary

The role involves leading Quality Management System operations to ensure compliance with Korea medical device regulations and ISO 13485 standards.

Salary

Competitive Salary; Short-term incentive via MIP; Flexible Benefits Package

Skills & Requirements

Must-have

  • Korea QMS adherence to ISO 13485
  • KGMP onsite audit experience
  • Post Market Surveillance support
  • Adverse Event Reporting execution
  • Field Corrective Action management

Nice-to-have

  • Class IV medical device handling
  • APAC project ownership experience
  • Strong autonomous problem-solving skills
  • Fluency in English and Korean languages

Key Requirements

  • Bachelor's degree in medical or biological science
  • 3-5 years of Quality Specialist experience in medical devices
  • Working knowledge of QARA Operations
  • Experience with KGMP onsite audits
  • Bilingual proficiency in English and Korean

Work Rights

Not specified

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