Manufacturing- Quality Engineer (Process Excellence & ISO audit)- Linkou
On-siteLinkou, Taiwan, Taiwan
Job Summary
Lead ISO 9001 audits and coordinate internal and external certification efforts, defining annual strategies and risk-based planning aligned with ASML quality priorities. Drive root cause analysis and CAPA closure for audit findings while coaching process owners on compliance and audit-ready behaviors. Own selected L3/L4 manufacturing processes to define KPIs, clarify RACI matrices, and ensure documentation aligns with ISO clauses. Govern Document Control Center practices to manage version-controlled procedures and assess change impacts on quality and operational risk. Consolidate learning materials and competence frameworks for the Linkou Factory while collaborating with Manufacturing, Engineering, and Logistics stakeholders to align on process expectations. Provide management-level insights on audit trends and systemic gaps to support continuous improvement.
Required Qualifications
- ISO 9001 audit leadership
- Lead Auditor / Audit Coordinator experience
- External certification audit support experience (e.g., BSI)
- Root cause analysis (RCA) capability
- CAPA definition and follow-up closure
- Process ownership or quality representative experience
- Business Process Management (BPM) principles application
- Document Control Center (DCC) governance
- Procedure, work instruction, and record version control
- Change impact assessment for quality, compliance, and operational risk
Desired Qualifications
- Knowledge Management & Manufacturing Academy Enablement experience
- Competence frameworks development
- Skill status tracking across Manufacturing and Quality
- Structured knowledge management practices
- Process and quality knowledge capture, standardization, and sustainability
- ASML quality priorities alignment
- Process effectiveness and maturity improvement
- Plan–Do–Check–Act (PDCA) methodology
- Stakeholder collaboration with Manufacturing, Engineering, Logistics, and Quality
- Management-level insights on audit trends, systemic gaps, and maturity progression
- Inclusion and diversity values
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