Job Information
Zimmer Biomet QA Associate in Seoul, South Korea
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
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
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
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 3 months-1 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
EOE/M/F/Vet/Disability
Zimmer Biomet
- Zimmer Biomet Jobs