Position Summary
• The QA Specialist is responsible for hands-on operation, governance, and effective verification of the company’s Quality Management System (QMS).
• Serves as a system owner and audit lead, working closely with senior-level process owners to define and execute auditing procedures, and to lead internal, external, and regulatory audits, ensuring product quality, regulatory compliance, and audit readiness for Swagelok and Custom Solutions products.
• The QA Specialist serves as a key interface with Corporate Quality teams in the USA and global quality stakeholders, ensuring alignment with ISO 9001, Swagelok Quality System requirements (SQS-D), and corporate governance expectations.
Key Responsibilities
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1) Quality Assurance System
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• Operate, maintain, and continuously improve the QMS across the defined Quality Management System processes.
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• Ensure QMS compliance with ISO 9001, Swagelok Quality System requirements (SQS-D), and applicable customer standards
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• Review, control, and improve QMS documentation, including processes, procedures, and work instructions
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• Work with respective process owners (manager-level and above) to ensure effective implementation and ownership of QMS requirements.
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• Lead QMS-related training, communication, and awareness activities across the organization.
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• Verify that corporate quality policies and customer requirements are properly embedded into local processes.
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- 2) Process Quality & Audit Management
- • Monitor and verify adherence to quality standards across production (Custom Solution), service, and support processes.
- • Plan, conduct, and document internal quality audits to assess compliance, process effectiveness, and operational risk.
- • Conduct supplier and subcontractor quality audits as required and ensure timely closure of corrective actions.
- • Review corrective and preventive actions and verify effectiveness based on objective evidence.
- • Identify, escalate, and report systemic risks and recurring quality issues to the Quality Manager, supported by data-driven analysis and recommendations.
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- 3) Internal & External Audit Readiness
- • Serve as the primary QMS point of contact for corporate audits (SQS-D), ISO 9001 third-party audits, customer quality audits, and regulatory inspections.
- • Conduct gap analyses and risk assessments prior to audits and leads pre-audit improvement and remediation activities.
- • Coordinate audit schedules, documentation readiness, and cross-functional stakeholder alignment.
- • Manage audit findings, including root cause analysis, corrective action planning, implementation, and effectiveness verification.
- • Promote and maintain a state of continuous audit readiness rather than point-in-time audit preparation.
- • Coordinate and support product certification and approval activities, including applicable national and international certifications (e.g., KS, KGS), ensuring compliance with regulatory and customer requirements.
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- 4) Quality Performance & KPI Management
- • Define, maintain, and track key quality KPI related to system performance, process compliance, and audit outcomes.
- • Analyze KPI trends to identify systemic risks and prioritize improvement initiatives.
- • Prepare structured quality performance reports for management review and Corporate Quality communication.
- • Support data-driven decision making through clear visualization and analysis of quality metrics.
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- 5) Global Quality Communication & Collaboration
- • Maintain regular communication with the Corporate Quality team in the USA regarding QMS status, audit outcomes, and improvement initiatives.
- • Participate in global (Corporate and APAC) quality meetings and share best practices.
- • Ensure timely and clear communication in English for reports, audits, and global alignment activities.
- • 10+ years of experience in Quality Control, Quality Assurance, and Quality Management.
- • Bachelor’s degree or higher in Engineering, Quality or a related discipline.
- • Practical experience operating and auditing QMS aligned with ISO 9001
- • Strong understanding of process-based quality management and risk-based thinking.
- • Hands-on experience conducting internal audits
- • Experience working with senior stakeholders or process owners is strongly preferred.
- • Business level proficiency in English and Korea, both written and spoken.
- • Hands-on experience in handling customer complaints, customer quality issues, nonconformances, and corrective and preventive action (CAPA) processes.
- • Experience in preparing structured technical reports and customer-facing quality documentation.
- • Integrity
- • Accountability
- • System thinking
- • Clear Communication
- • Analytical & Risk-Based Thinking
- • Quality-First & Compliance Mindset
- • Continuous Improvement Mindset
- • Teamwork & Cross-Functional Collaboration
- • Good in spoken and written English
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