[글로벌 의료기기] QA Manager

(주)써치포리더스

모집부문 및 자격요건

담당업무 자격요건 인원

[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]

    근무부서: QA팀
    직급/직책: 과장, 팀장

[자격요건]

경력사항: 경력(7년 이상 )
학력사항: 대학교(4년)졸업
직무기술: 의료기기


1 명

근무조건

  • 고용형태: 정규직
  • 근무부서: QA팀
  • 급여조건: 연봉 6000 ~ 7000 만원

전형단계 및 제출서류

  • 전형단계: 서류전형 > 면접진행 > 최종심사 > 최종합격
  • 추가 제출서류
    이력서, 자기소개서

접수방법

채용시

  • 접수방법: 인크루트 채용시스템, 이메일
  • 접수양식: 인크루트 이력서, 자유양식

기타 유의사항

  • 입사지원서 및 제출서류에 허위사실이 있을 경우 채용이 취소될 수 있습니다.

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