[Purpose Statement]
The purpose of this role is to provide advanced Quality Systems, Commercial Quality, Distribution Quality, Post-Market Quality, and Regulatory Compliance support for the Korea Affiliate. This position serves as a key Quality representative for assigned processes to ensure compliance with Boston Scientific Quality System requirements, Korean medical device regulations, KGMP expectations, and applicable local procedures. This role independently manages assigned quality processes across the commercial product lifecycle, including quality system implementation, regulatory inspection readiness, distribution and 3PL quality oversight, product handling and service-related quality activities, post-market quality processes, and continuous improvement initiatives. The position partners closely with Global, APAC, and local cross-functional stakeholders to identify quality and compliance risks, translate requirements into practical operating processes, and support business continuity, patient safety, and product quality.
 
[Key Responsibilities] 
1. Quality Systems & Regulatory Compliance

• Maintain and support the Korea Affiliate Quality Management System (QMS) in compliance with Boston Scientific Quality System requirements and applicable Korean medical device regulations
• Assess the impact of global, APAC, local procedural, and regulatory changes, and support implementation of required actions including document updates, training, and follow-up activities
• Support Management Review, Internal Audits, document control, and quality record management activities to ensure an effective and inspection-ready Quality System
• Support KGMP certification and renewal activities, as well as inspections and audits conducted by MFDS and other regulatory authorities
• Identify quality and regulatory risks associated with product launches, supply chain changes, new business initiatives, and business transfer projects, and collaborate with stakeholders to implement appropriate mitigation actions

 
2. Commercial & Distribution Quality

• Support compliance with quality requirements throughout the distribution lifecycle of imported medical devices, including receipt, inspection, storage, release, returns, and disposition
• Participate in quality management activities for 3PL warehouses, suppliers, distributors, and outsourced service providers
• Establish and support appropriate quality processes for various supplier relationships (e.g., SFMD, TPI, 3PL), including quality agreements, change control, supplier qualification, KPI reviews, SCARs, and on-site audits
• Support quality activities related to product launches, inventory management, warehousing, and commercial operations
• Conduct distribution risk assessments (e.g., DPRA) and support implementation of related improvement initiatives

 
3. Capital Equipment & Service Quality

• Support quality activities related to installation, servicing, field service operations, and service center management
• Perform validation and qualification activities required by the Quality System, including warehouse facility qualification and software validation
• Support testing, certification, and documentation activities related to used medical devices
• Collaborate with Operations, Technical Service, Supply Chain, Regulatory Affairs, and other stakeholders to manage quality risks associated with product handling and service processes

 
4. Post-Market Quality & Continuous Improvement

• Manage or support post-market quality processes including complaint handling, vigilance reporting, foreign matter reporting, UDI management, field actions, and product recalls
• Conduct investigations, root cause analysis, risk assessments, corrective and preventive actions (CAPA), and effectiveness verification activities related to quality issues and nonconformances
• Identify quality signals and regulatory risks associated with products and processes, and ensure appropriate escalation and follow-up actions
• Participate in continuous improvement, digitalization, and process automation initiatives that enhance compliance, operational effectiveness, and quality culture

[Required Qualifications]

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Medical Technology, Quality, Regulatory Affairs, or related discipline
• Minimum 7 years of experience in quality system management within a regulated industry
• Working knowledge of ISO 13485, medical device quality system requirements, and Korean medical device regulations
• Ability to independently manage assigned processes, coordinate cross-functional actions, and escalate quality or compliance risks appropriately
• Strong written and verbal communication skills in Korean and English
• Strong documentation, analytical thinking, prioritization, and stakeholder management skills

 
[Preferred Qualifications]

• Lead Auditor, Internal Auditor, CAPA Mentor, or equivalent quality certifications
• Experience with eQMS systems, data analytics, Power BI, automation, or AI-based productivity tools
• Internal Auditor, Lead Auditor, CAPA, Six Sigma, Lean, Quality Engineer, Regulatory Affairs, or equivalent certification preferred
• Project management experience with the ability to lead or coordinate cross-functional initiatives under ambiguity