Seoul, Korea, Republic of, Korea, Republic of
Hybrid
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Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Seoul, Korea, Republic ofJob Description:
DePuy Synthes is recruiting for a HSD/QA Lead Korea
Job Overview
The a HSD/QA Lead – Korea is responsible for Handling Storage and Distribution (HSD)–related quality activities within Commercial Quality for the Korea market. This role ensures compliant execution of distribution, storage, handling, and post‑market processes in alignment with regulatory requirements and internal quality standards. The position plays a critical role in safeguarding patient safety, ensuring regulatory readiness, and supporting reliable product supply by partnering closely with Commercial, Regulatory Affairs, Supply Chain, and Global Quality teams.
Key Responsibilities
Lead and oversee HSD‑related Commercial Quality activities for the Korea market, ensuring compliance with applicable regulations and quality system requirements.
Serve as the primary Commercial Quality contact for HSD and local QA-related activities in Korea.
Provide quality oversight for distribution, storage, handling, and logistics activities across the local network, including product disposition, shipment holds, and distribution-related quality decisions
Partner with Supply Chain, Commercial, and Regulatory Affairs teams to ensure compliant product distribution and lifecycle management, and product license renewal activities, providing quality leadership and timely delivery of quality-related documentation and post-market evidence required for regulatory submissions.
Lead quality review and approval of local labeling, eIFU, and product information changes in collaboration with Regulatory Affairs.
Lead and ensure compliance with UDI management, supply record reporting, and product traceability requirements, where applicable.
Support Lead and oversee post‑market surveillance activities, including complaint handling ,field action , recalls and trend analysis coordination as required.
Monitor HSD‑related quality risks, trends, and performance metrics; drive corrective and preventive actions.
Support Lead and coordinate internal audits, external audits, 3rd party audit and health authority inspections related to HSD and Commercial Quality processes.
Drive continuous improvement initiatives to strengthen compliance, consistency, and operational effectiveness.
Qualifications
Education:
Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, Supply Chain, or a related discipline (required).
Advanced degree in a scientific, quality, or regulatory field (preferred).
Experience and Skills:
Required:
Typically 4-6 years of progressive experience in Quality, Regulatory, Compliance, roles within a regulated industry.
Demonstrated experience supporting distribution, logistics, or post‑market quality activities.
Strong understanding of quality system requirements and regulatory expectations for commercial operations.
Experience supporting audits, inspections, or regulatory assessments.
Ability to analyze quality risks and translate requirements into practical actions.
Preferred:
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with Korean regulatory and distribution quality requirements.
Experience working in a multinational or matrixed organization.
Prior experience leading or coordinating HSD or Commercial Quality activities.
Quality or Regulatory certifications (e.g., ASQ, RAC).
Strong stakeholder management, communication, and problem‑solving skills.
Other:
Language: Korean required; English proficiency preferred.
Travel: Limited; occasional domestic travel within South Korea.
Certifications: Quality or Regulatory certifications preferred but not required.
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Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
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Required Skills:
Preferred Skills:
Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)Want to know if this job is worth applying to?