- 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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QA Associate - Seoul, 대한민국. - Zimmer Biomet
설명
JOB DESCRIPTIONAt 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
Post-market surveillance activities
Compliance with MFDS requirements
Expected Areas of Competence
Education/Experience Requirements
Travel Requirements
EOE/M/F/Vet/Disability
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