QMS Engineer
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.
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• 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.
Perks and Benefits
Health and Wellness
- Health Insurance
- Health Reimbursement Account
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- FSA
- HSA With Employer Contribution
- Fitness Subsidies
- On-Site Gym
- Pet Insurance
- Mental Health Benefits
- Virtual Fitness Classes
Parental Benefits
- Birth Parent or Maternity Leave
- Adoption Assistance Program
Work Flexibility
- Flexible Work Hours
- Remote Work Opportunities
- Hybrid Work Opportunities
Office Life and Perks
- Casual Dress
- On-Site Cafeteria
Vacation and Time Off
- Paid Vacation
- Paid Holidays
- Personal/Sick Days
- Leave of Absence
- Summer Fridays
Financial and Retirement
- 401(K) With Company Matching
- Performance Bonus
- Relocation Assistance
- Financial Counseling
Professional Development
- Tuition Reimbursement
- Promote From Within
- Mentor Program
- Shadowing Opportunities
- Access to Online Courses
- Internship Program
- Work Visa Sponsorship
- Leadership Training Program
- Associate or Rotational Training Program
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)