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외국계 의료기기 RA/QA부서

핵심 정보

경력
신입·경력 3년 ↓
학력
대졸(4년제) 이상(예정자 가능)
근무형태
정규직 수습기간 3개월
우대사항
급여
면접 후 결정
근무요일
주 5일(월~금)
근무지역
서울 강남구
최저임금계산에 대한 알림 하단에 명시된 급여, 근무 내용 등이 최저임금에 미달하는 경우 위 내용이 우선합니다. 본 채용정보는 2024년 1월 1일 부터는  2024년 최저임금을 준수 합니다.

본 채용정보는 마감되었습니다.

라디오미터코리아(유)에서 채용공고가 시작되면 이메일로 알려드립니다.

상세요강

Job Description

Position : Quality Assurance Specialist - Radiometer Korea.


About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions decisions that in the end help save lives.


On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.


Want to know more about our mission and vision? Click on the link:

Link of YouTube video


Our people

At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.


If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.5B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.


At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.


Description

Radiometer was established by Danish engineers Carl Johan Schrøder and Børge Aagaard Nielsen in 1935. The headquarters, Radiometer Medical ApS, are located in Brønshøj in Copenhagen and is owned by US-based Danaher Corporation, a worldwide technology leader owning a broad spectrum of companies. For subsidiary in Korea, Radiometer Korea was established in 2013 at Chung-Dam Dong.


Your area of responsibility will be to ensure market approvals for Radiometer’s different product areas such as Immunoassays, Transcutaneous Monitors, Samplers, IT Solutions, and the Blood Gas products this requires special knowledge within In Vitro Diagnostics- and Medical Device legislation.


The job

To become successful, you must cooperate cross-functionally with Head Quarter RA/QA and other departments. Your responsibilities and tasks will include:


  1. Participate in process improvements and creation of SOPs in the QA/QC area.

  2. Implement of refurbishment process for analyzers (Self-testing and essential requirement of IEC 61010)

  3. Support to cross-functional projects (Registration, Quality Assurance, Quality Control etc.)

  4. Maintain a Quality Management System(QMS) according to Korea Medical Device Regulation.

  5. Support internal warranty process and communicate with Head Quarter (Service Desk)

  6. Support local warehouse control

  7. Support GMP on site or desk review audit

  8. Implement and monitor corrective action for Field Action Notice and/or Technical Update from Head Quarter or MFDS risk information division.

The position does not require a lot of travelling, but some days during the year must be expected.


We offer you

A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Radiometer Korea and Head Quarter at Denmark or abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people’s lives. We offer you ‘freedom with responsibility’, opportunities for training and career development, and a wide range of staff benefits.


For further information, please contact Regulatory Affairs/Quality Assurance Specialist, Jerry Kang(강영민차장) at tel. 02-2056-9303 / e-mail. jerry.kang@radiometer.kr


Qualifications


  • Bachelor’s Degree in Science, Engineering, Pharmacy, Biology, Biochemistry or similar

  • The preferred candidate has: New recruit ~ 2 years or more

    • Experience with the medical device legislation (IVDD, MDD Electric device)

    • Experience with work relations in different cultures

    • Experience with RA/QA support to cross-functional projects

  • Fluency in English, both written and spoken.

  • Experienced MS office (Excel, PowerPoint, Word, and Outlook) user


You must be passionate and committed about what you do, as well as:

 

  • Have good analytical skills.

  • Be positive and open-minded, adding energy to the team by taking responsibility and being engaged and committed about what you do.

  • Have strong communication skills, communicating effectively across teams and functions.

  • Focused on targets and results, acting proactively and working well independently as well as in teams.

  • Able to handle and prioritize many projects at the same time.


Organization: Radiometer Korea (Medical Devices)

Primary Location: Seoul Korea Chung-Dam Dong (Yeongdong-daero Gangnam-gu)

Schedule: Full-time (9:00AM~6:00PM), Monday~Friday



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복리후생

지원금/보험
건강검진, 각종 경조사 지원, 통신비 지원, 자녀학자금
급여제도
퇴직연금, 상여금, 우수사원포상, 4대 보험
선물
명절선물/귀향비, 창립일선물지급, 생일선물/파티
교육/생활
워크샵
근무 환경
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리프레시
연차, 경조휴가제, 반차

근무지위치

(135-763) 서울 강남구 청담동 53-8 은성빌딩 15층 서울 7호선 청담역

지도 보기

접수기간 및 방법

마감되었습니다.

시작일
2017.01.12 14:00
마감일
2017.02.03 16:20

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기업정보

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신동현
기업형태
중소기업, 외국 법인기업
업종
상품 종합 도매업
설립일
2013년 9월 13일 (업력 12년차)
매출액
185억 2,713만원 (2023년 기준)
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