- Support of quality documentation (Quality Manual, Procedures, PMF, Local Language Label, etc)
- ISO 13485/MFDS/Corporate audit
- CAPA & Risk management
- Supplier management
- Quality release of repaired products
- Complaint handling and follow-up in Korea
- Assess the reportability of global complaints and report foreign adverse events to MFDS
- Field action including recall activity, quality hold, issue evaluation, etc
- PMS data collection for license renewal and reevaluation
- Maintenance of KGMP certificates, including on-site audits and document audits
- UDI registration and maintenance and Monthly supply report
- Track and follow up on the new regulations/requirements
- Competent English language skills (reading, writing, listening, and fluent speaking)
- Comprehensive knowledge of MFDS regulations
- Strong writing and communication skills; ability to communicate effectively at multiple levels including with regulatory authorities
- Knowledge of medical device products (Implants and/or electronic devices) and regulations and ability to interpret them
- Ability to manage multiple projects
- Responsible, professional, detail-oriented
- Strong computer skills
- Bachelor's Degree in life sciences, technical (engineering), or related field; advanced degree strongly preferred
- Minimum of 3 months-1 year of experience required in Quality Assurance
- Certifications an advantage including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC
- No reason for disqualification for oversea travels
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Sales Associate
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Sales Associate
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Amazon Seoul, 대한민국. 풀타임· Cloud Support Associate (CSA)는 AWS 서비스를 사용하는 고객을 대상으로 장애에 대한 troubleshooting 및 general guidance 등의 기술지원을 수행합니다. CSA는 소속된 Profile에 따라 다수의 AWS 서비스를 지원합니다. Profile은 다음과 같이 분류되어 있습니다. · Computing (Linux/Windows) · Networking, Security · Storage & Contents Delivery Network · Deploy ...
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Coupang Seoul, 대한민국.회사 소개 · 쿠팡은 고객 감동 실현을 위해 존재합니다. 고객들이 "쿠팡 없이 그동안 어떻게 살았을까?" 라고 말할 때, 비로소 우리의 미션을 실현하고 있음을 알 수 있습니다. 고객들의 쇼핑과 식사, 생활 전반을 편하게 만들겠다는 유일한 집념으로 쿠팡은 수억 달러 규모의 이커머스 산업 전반의 혁신을 이끌고 있습니다. 쿠팡은 가장 빠르게 성장하는 이커머스 기업 중 하나로, 국내 커머스 업계에서의 독보적인 입지와, 고객 신뢰를 구축했습니다. · 쿠팡은 스타트업 문화를 기반으로 한 글로벌 대형 상장사라 ...
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Research Associate
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Research Associate
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Sr. Associate
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Associate, Marketing
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Sales Associate
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QA Associate - Seoul, 대한민국. - Zimmer Biomet
설명
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward.As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world.
To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.
We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.Job Summary
Responsible for supporting the Quality Management System and for ensuring quality system compliance in Korea.
Principal Duties and Responsibilities
Management of quality system
Expected Areas of Competence
Education/Experience Requirements
Travel Requirements
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