[한국애보트] 당뇨사업부 QA Manager

Job Purpose : 

-  Act as Quality representative for ADC South Korea and manage all the relevant routine quality activities with ADC South Korea.

- Be the primary point of contact and person in charge to ensure QMS compliance with respect to internal Abbott requirements and to external to regulatory requirements in South Korea

Knowledge, Experience and Education :

• Education:  Bachelor's degree
• Years of experience, both overall and any industry-specific experience needed:   Minimum 10 years in Medical Device industry or equivalent.
• Other qualifications/certifications: Prefer lead auditor certificate for ISO13485

Major Accountabilities  :

• Responsible as Quality representative for ADC South Korea managing all routine Quality related tasks (eg. Supplier/Distributor Qualification and Management, SCAR/CAPA, QMS, Management Review, Document Control, Audits)
• Ensure audit compliance and be the main auditee for internal and external audits/inspections
• Ensure consistent application of relevant Quality Assurance policies, programs, and systems by clearly defining specific Abbott and Abbott Diabetes Care SOPs and locally developed procedures that govern critical to success business functions. Recognition that some degree of flexibility to execute activities appropriate to local requirements and market needs is also required.
• Elevate issues or significant events (product performance issues) to the appropriate facility with relevant facts and work closely with local CX manager to provide feedback and corrective actions appropriate to the issue
• Document owner of South Korea documents and procedures.
• Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met. Respond to manufacturing site requests (e.g., Field Actions, quality holds, reworks, complaint product return