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[담당업무]
% WEIGHTING OF RESPONSIBILITY 1
ESSENTIAL DUTIES AND RESPONSIBILITIES
65% Establish and maintain a Quality Management System (QMS) for the ILS Korea site. Ensure that the QMS coincides with the Korean logistics provider’s processes and systems, while also ensuring it is compatible with ILS Corporate and other ILS sites. Work with International Regulatory to understand the local regulations and ensure the QMS are meeting these needs.
15% Establish processes for reporting (complaints and FSCA) that are compliant with the local regulations and compatible with ILS Corporate processes. Ensure complaint decision tree processes are established and resources are in place to execute.
10% Work with the local sales operations and marketing teams to understand the business needs for Korea, and how the quality team can help support these demands.
5% Work with other local distributors and work with Sales Operations to ensure the proper documentation (quality agreements, distribution authorization letters) are in place and active.
5% Other Duties as assigned
Job Requirements
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
Education: Bachelor’s degree in a scientific or engineering discipline with 7 years of experience in a regulated industry.
Experience:
Prior experience with Medical Devices and Instruments is required.
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), MEDDEV 2.12-1, European Union Medical Device Regulation, KFDA Medical Device Act.
Demonstrated ability to:
develop and maintain key internal and external professional relationships.
generate results, enthusiasm, high levels of trust, commitment, and a sense of urgency.
quickly gain the respect and support of own staff and fellow leaders.
build customer relationships with Integra LifeSciences’ partners in order to facilitate strong forecasting, product launch planning, and execution, and to ensure effective customer problem resolution
Exemplifies Leadership Integrity and Courage
Ability to travel up to 10% of the Time
[근무부서 및 직급/직책]
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[자격요건] 경력사항: 경력(7년 이상 )
학력사항: 대학교(4년)졸업
직무기술: 의료기기
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