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ABOUT ABBOTT :
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Diabetes Division(ADC) :
We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
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 returns)
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com