QA Associate 계약직 1명
< Job Function > Regulatory Affairs/Quality/Reimbursement
< 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 - Management 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
* Post-market surveillance activities - 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
* Compliance with MFDS requirements - 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
< Expected Areas of Competence (i.e. KSAs) >
- 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
< Education/Experience Requirements >
- Bachelor’s Degree in life sciences, technical (engineering), or related field; advanced degree strongly preferred - Entry level to less than1 year of experience required in Quality Assurance - Certifications an advantage including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC
< Travel Requirements > - No reason for disqualification for oversea travels
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