[Zimmer Biomet Korea] QA Specialist 경력직 채용

< 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

- Minimum of 4-5 years 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