Quality Manager, Medical Devices Korea

Grifols Shared Services North America, Inc; Hong Kong; Híbrido; HKD 404.000 - 519.000; Jornada completa

Descripción de la vacante

Grifols is seeking a Quality Manager to lead the affiliate's Quality System in Korea, ensuring compliant distribution of medical devices and IVD products. You will act as the in-country quality contact for customers and authorities, coordinate recalls and CAPAs, and collaborate with Regulatory and Corporate Quality teams.

The role requires 3+ years in Quality/Regulatory roles in a multinational, with ISO 9001 knowledge desirable and SAP/MS Office proficiency. Korean language fluency is essential.

Formación

• 3+ years of experience in Quality or Regulatory roles within a multinational environment.
• Experience with medical devices or IVDs preferred.
• Experience implementing or maintaining a Quality System (ISO 9001 desirable).

Responsabilidades

• Implement and maintain the affiliate’s Quality System in line with corporate policies and Korean regulatory requirements.
• Manage product distribution activities (storage, shipping, transport) and ensure licenses remain valid.
• Act as in-country quality contact for customers, distributors and authorities; coordinate with Grifols sites for follow-up.
• Qualify suppliers, perform assessments, and conduct audits or desk audits when required.
• Coordinate recalls, product incidents, deviations, CAPAs and change controls with timely escalation.

Conocimientos

Quality Systems

Regulatory Affairs

Audits

ISO 9001

Korean language

Educación

Bachelor in Pharmacy

Herramientas

SAP

MS Office

Descripción del empleo

Grifols is seeking a Quality Manager to lead the affiliate's Quality System in Korea, ensuring compliant distribution of medical devices and IVD products. You will act as the in-country quality contact for customers and authorities, coordinate recalls and CAPAs, and collaborate with Regulatory and Corporate Quality teams.

The role requires 3+ years in Quality/Regulatory roles in a multinational, with ISO 9001 knowledge desirable and SAP/MS Office proficiency. Korean language fluency is essential.