Job Description
What you’ll do:
1. QMS Documentation & Document Change Control (DCC)
•Own and maintain the QMS document hierarchy (Level 1–4): Quality Manual, Procedures (SOP), Work Instructions, and Forms.
•Manage the Document Change Control (DCC) process — review, approve, distribute, and archive controlled documents in a timely manner.
•Audit current Level 4 documents (SOPs and Work Instructions) for completeness and accuracy; identify and close gaps.
•Ensure all documents are version-controlled and accessible to relevant personnel.
•Process change requests from QC, QE, and Production teams within agreed turnaround time.
•Control and management of external documents related to EQMS
•Build and maintain a comprehensive knowledge management system to ensure effective management
2. EQMS/ISO 9001 Certification & Compliance
•Serve as the primary owner of EQMS/ISO 9001 certification — maintain compliance with all applicable requirements and manage the recertification cycle.
•Monitor changes to ISO standards and update the QMS accordingly.
•Prepare and coordinate Management Review meetings, including data compilation and presentation.
•Maintain and update the Quality Manual to reflect current organizational structure and processes.
3. Internal Audit Program
•Develop and execute the annual internal audit schedule across all quality-related functions (QC, QE, SQE, Production).
•Conduct internal audits to verify that the QMS is implemented and followed correctly.
•Issue audit findings and non-conformances; track corrective action closure with relevant teams.
•Train internal auditors as needed to build organizational audit capability.
4. Customer Audit & External Assessment Coordination
•Coordinate all customer audits and external third-party assessments — serve as the primary point of contact and lead preparation activities.
•Compile audit packages, facilitate audit execution, and manage follow-up on customer findings.
•Track and close corrective actions arising from customer and external audits.
5. Training Management
•Develop and maintain the annual Quality training plan for all relevant personnel.
•Coordinate training delivery (internal and external), maintain training records, and ensure compliance with ISO training requirements.
•Publish and manage OPL (One Point Lessons) — consolidate OPLs previously scattered across QC and QE teams into a unified system.
•Support onboarding of new Quality team members with structured orientation training.
6. MOC (Management of Change) Process
•Administer the Management of Change (MOC) process — review, document, and track engineering and process changes with quality impact assessment.
•Coordinate with QE, ME, and Production teams to ensure all changes are properly evaluated and documented before implementation.
•Maintain MOC records and ensure traceability to related documents (Control Plans, SOP, drawings).
7. Quality Culture & System Improvement
•Act as an advocate for quality discipline — drive adoption of QMS processes across all teams.
•Identify systemic gaps in the quality management system and lead improvement initiatives.
•Provide regular QMS performance reports to Quality Manager, including audit results, document status, training completion, and non-conformance trends.
8. Quality Data Pipeline & Infrastructure
•Build and manage a quality data to consolidate cross-functional quality KPIs (FPY, Cpk, defect Pareto, audit scores...etc.).
•Develop automated data quality validation rules (completeness, accuracy, consistency) to ensure data integrity across sources.
•Deliver Power BI / Tableau dashboards for QE, QC, and Plant Management consumption.
9. Special projects or other assignments as assigned by the supervisor
Qualifications:
- Bachelor's degree or above in Engineering, Industrial Management, Quality Management, or related field.
- Minimum 3–5 years of experience in a QMS, Quality Systems, or Quality Assurance role in a manufacturing environment.
- Demonstrated experience managing ISO 9001 certification — hands-on involvement in audits, document control, and system maintenance.
- Experience in rubber, polymer, consumer goods, or precision manufacturing is a plus.
Skills:
• Strong knowledge of ISO 9001:2015 requirements and audit methodology.
• Proficiency in document control systems; experience with electronic QMS platforms is a plus.
• Familiarity with quality tools: FMEA, Control Plan, SPC, 8D, PDCA.
• Proficient in Microsoft Office (Word, Excel, PowerPoint); data analysis skills preferred.
• Data visualization tools: Power BI or Tableau.
• Statistical knowledge: SPC, Cpk/Ppk, Gauge R&R, process capability analysis.
• High attention to detail and strong organizational skills — able to manage multiple documents and timelines simultaneously.
• Strong written and verbal communication in both Mandarin and English.
• Ability to influence and drive accountability across cross-functional teams without direct authority.
• Self-driven and proactive — able to identify gaps and take ownership of improvement initiatives.
• Comfortable with audit and review processes; able to deliver clear, professional findings.