About the role
Job Description
Agilent Korea. The statutory and operational responsibilities associated with the Korea Quality Manager role will be the primary responsibility of this position. Additional regional responsibilities may also be performed to provide oversight, processes, and tools to the operating companies and channel partners (importers, distributors, sellers/resellers, dealers, service providers, sales & marketing agents) who execute commercial quality activities for Agilent in the Asia Pacific (APAC) region.
This role involves working with cross-functional teams to execute, improve, maintain and monitor these regional quality activities. The Manager will report directly to the International Quality Lead. The candidate must meet the applicable statutory qualification requirements to serve as the registered Quality Manager for IVD medical devices in South Korea.
Essential Duties & Responsibilities
Overview
The Manager, Regional Quality Assurance (QA) will serve as the registered IVD Medical Device Quality Manager(품질책임자) for Agilent Korea. The statutory and operational responsibilities associated with the Korea Quality Manager(품질책임자) role will be the primary responsibility of this position. Additional regional responsibilities may also be performed to provide oversight, processes, and tools to the operating companies and channel partners (importers, distributors, sellers/resellers, dealers, service providers, sales & marketing agents) who execute commercial quality activities for Agilent in the Asia Pacific (APAC) region.
This role involves working with cross-functional teams to execute, improve, maintain and monitor these regional quality activities. The Manager will report directly to the International Quality. The candidate must meet the applicable statutory qualification requirements to serve as the registered Quality Manager(품질책임자) for IVD medical devices in South Korea.
Essential Duties & Responsibilities
Main Responsibilities (as South Korea Registered Medical Device and IVD Quality Manager(품질책임자))
Manage and strengthen governance and quality systems of Agilent Korea IVD Import License Model against the MFDS regulations. Current model: warehouse (storage) and testing (inspection/lab) activities are outsourced.
Responsible for key commercial quality activities: outsourced warehouse oversight, contractual agreement, testing review, product quality inspection, product release approval, inspection/audit readiness, deviation/CAPA management, and post market activities.
Maintain Korea QMS documentation and records: procedures, document change records, communication records, facility maintenance records, equipment maintenance/calibration/repair records, customer complaints, deviations, corrective/preventive actions, training records, test and inspection records, and product release records.
Perform and/or host audits and inspections, including MFDS Audits for various licenses, Warehouse Audits, and KGMP Audit on registered Agilent manufacturing sites.
Provide training to relevant Korea personnel on Commercial Quality requirements, procedures and responsibilities.
Receive the mandatory 8-hour training annually per MFDS requirement.
Prepare Medical Devices reports, including Import Annual Reports(의료기기 실적보고) and Pre-Import Reports (표준통관예정보고).
Additional Regional Responsibilities
Establish QMS processes and tools systems to ensure consistent execution of commercial quality activities across APAC region.
Negotiate quality agreements and/or the quality elements of contracts with the APAC operating companies and channel partners to ensure accountability.
Direct customer-reported quality signals and feedback related to commercial activities to the International Quality to coordinate the correct QMS processes for issue management and escalation.
Support regional audits/inspections, and internal reviews related to commercial quality processes.
Partner with regulatory and regional teams to identify quality activities performed by other functions and establish communication channels and community of practice.
Enable consistent quality execution across markets and commercial organizations in APAC through processes and training programs.
Assist in a risk-based approach for oversight of compliance and the health of the commercial quality processes.
Track APAC regional commercial quality issues, trends, and risks.
Qualifications
Education
Bachelor of Science (BS or BSc) degree in Engineering, Science, Life Science, Medical, Clinical Laboratory Science, or another relevant technical discipline is required, or directly equivalent experience in Quality Assurance. The candidate must meet the applicable statutory qualification requirements to serve as the registered Quality Manager (품질책임자) for IVD medical devices in South Korea. Eligibility must be verified before appointment.
Advanced degrees, including an MBA or a relevant professional certification in Quality Management, Engineering, Life Sciences, Medical Devices, or Regulatory Affairs are preferred.
Experience
Minimum of 8 years’ experience in Quality Assurance, Regulatory Affairs, and Commercial Quality, including substantial hands-on experience in medical device or IVD Quality Assurance and import quality operations.
Prior experience serving as, or directly supporting, a registered Quality Manager (품질책임자) for a medical device or IVD manufacturer or importer in South Korea is strongly preferred.
Experienced in Regulated Product Environments, such as Medical Devices, In-Vitro Diagnostic Devices (IVDs), BioPharma, or other related Life Science industry, with medical device or IVD experience strongly preferred.
Experienced in conducting and/hosting audits and inspections, with strong knowledge of applicable Korean medical device and IVD requirements, KGMP, and relevant international standards and regulations, including US FDA CFRs, EU IVDR, MDSAP requirements, ISO 13485, ISO 14971, ISO 9001, and the application to establish a strong QMS.
Essential Skills
Professional proficiency in Korean and English, including the ability to read, interpret, and prepare regulatory and quality documentation.
Strong understanding of both International and APAC country-specific compliance considerations, including and not limited to South Korea, Japan, Australia/New Zealand, Singapore, Malaysia, and Thailand.
Experience working cross functionally with Marketing, Sales, Commercial Compliance, Legal Compliance, Field Service, Regulatory, and Quality teams.
Proven ability to manage risks and ensure consistency across regional organizations. Escalate issues promptly and concisely into the International Quality Lead.
Proven ability to take independent actions to initiate process improvement. Align actions accordingly with the International Quality.
Ability to engage, influence, and negotiate with stakeholders, including business group leaders and peers, in a matrixed environment.
Able to lead and manage the execution of processes, projects and programs within the APAC region.
Well-organized, able to multitask and prioritize competing tasks.
Advanced MS Office skills (Outlook, Word, Excel, PowerPoint).
Basic AI knowledge to facilitate efficiencies in day-to-day responsibilities (e.g. custom reports/dashboards, visualizations in analytical tools, metrics and data presentation).
Additional Details
This job has a full time weekly schedule. It includes the option to work remotely.Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.Travel Required:
OccasionalShift:
DayDuration:
No End DateJob Function:
Quality/RegulatoryOriginally posted on Himalayas
