Medtronic
Healthcare
QualitySystemsSpecialist
“Quality Systems Specialist at Medtronic. Skills: Quality Systems Management, Medical Device Regulation, Auditing. Ensure Korea QMS follows Korea medical device regulation. Maintain QMS procedures and quality records”
Industry & Context.
Excellent problem-solving skills
Onsite audit
What They're Looking For.
Must Have
Bachelor's degree in medical, biological science or equivalent, 3 - 5 years of relevant experience, Prior experience in a Quality Specialist role, Medical devices experience, Good understanding and working knowledge of QARA Operations, Effective written and verbal communication skills in English and Korean, Ability to work well within a team and autonomously, Achievement oriented, Ability to drive results with the highest quality standards, Excellent knowledge of MS Office products, High attention to detail and accuracy, Good prioritization and organizational skills, Excellent problem-solving skills, Korea Good Manufacturing Practice (KGMP) onsite audit experience, Medical devices class IV product handling experience
Nice to Have
Experience in medical devices preferred
What You'll Do.
Ensure Korea QMS follows Korea medical device regulation
Maintain QMS procedures and quality records
Establish training matrix
Assign training in learning management system
Conduct internal audit
Conduct corrective and preventive actions
Prepare Post Market Surveillance audit
Support Post Market Surveillance audit
Manage change control
Manage risk management
Participate local/APAC project for continuous improvement
Own local/APAC project for continuous improvement
Handle Product Complaint
Handle Adverse Event Reporting
Oversee Adverse Event Reporting
Oversee Foreign Material reporting
Execute Field Corrective Action (FCA)
Collaborate with global complaint and FCA team
How You'll Work.
Team & Collaboration
Global complaint and FCA team
Communication Scope
Written communication; Verbal communication
Process & Methodology
Continuous improvement
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