Responsibilities
1. QMS Governance, Standardization & Documentation
- Develop, maintain, and continuously improve Quality Policies, Procedures, SOPs, Work Instructions, and quality records, ensuring effective document control and governance.
- Establish and govern the framework for Product Quality Standards and Quality Control requirements across all sites.
- Drive standardization and harmonization of quality management processes to ensure compliance with ISO 9001, customer requirements, regulatory requirements, and internal governance standards.
- Lead QMS enhancement initiatives to improve process effectiveness, consistency, and operational efficiency.
2. Training, Competency & Quality Culture
- Develop and implement QMS training, competency assessment, and capability-building programs to promote a strong quality culture and enhance organizational quality maturity across functions and sites.
3. Audit, CAPA, Continuous Improvement
- Develop and manage the internal quality audit framework, including audit planning, methodologies, scoring mechanisms, and execution.
- Monitor and verify the timely and effective closure of audit findings, non-conformities (NCs), Areas for Improvement (AFIs), and CAPA actions.
- Govern CAPA, RCA, and continuous improvement processes to ensure sustainable resolution of quality issues.
- Analyze audit and quality performance data to identify systemic risks, trends, and improvement opportunities, while facilitating cross-functional problem-solving initiatives.
4. Quality Governance & Performance Management
- Coordinate and facilitate monthly Quality Governance Review meetings, including preparation of quality performance reports, audit results, CAPA updates, risk assessments, and action tracking.
- Develop, maintain, and report QMS-related KPIs and governance metrics to support management review and decision-making.
- Consolidate quality performance data, identify significant risks or systemic issues, and support management reporting and escalation processes.
5. Digital Quality & System Enhancement
- Support the digitalization of quality management processes and collaborate with IT and business stakeholders on system enhancement initiatives.
- Promote data-driven decision-making through effective use of quality analytics and reporting tools.
Regular travel within China and APAC regions is required.
Qualifications
- Bachelor's Degree in Quality Management, Industrial Engineering, Manufacturing Engineering, Operations Management, or a related discipline.
- Minimum 8 years of relevant experience in Quality Management Systems, Quality Assurance, or Quality Governance, including at least 5 years of hands-on experience in QMS implementation and governance.
- Proven hands-on experience in implementing, maintaining, and auditing ISO 9001-based Quality Management Systems, including development of Quality Policies, Procedures, SOPs, Work Instructions, forms, and quality records. Ability to independently manage QMS documentation, implementation, and governance activities in a hands-on individual contributor role.
- Experience in a multi-site manufacturing, sourcing, supply chain, or production environment is preferred.
- Fluent in English and Mandarin, with strong verbal and written communication skills.
- Willingness to travel regularly within China and the Asia-Pacific region, including Vietnam, Indonesia, India, Sri Lanka, Turkey, and Cambodia.
- Ability to effectively engage and influence stakeholders across different functions, cultures, and geographical locations.
- ISO 9001 Lead Auditor certification or equivalent is preferred.
- Additional quality certifications such as Six Sigma Green Belt/Black Belt, or related professional qualifications are advantageous.
Professional Competencies
- Proficiency in quality tools and methodologies such as RCA, 8D, and CAPA, supported by strong analytical and systematic problem solving skills.
- Strong technical writing and documentation skills, with the ability to develop, review, and maintain quality policies, procedures, SOPs, work instructions, and governance documents.
- Excellent communication, stakeholder management, influencing, and change management skills, with proven capability to lead cross-functional quality initiatives and manage interactions with auditors, customers, suppliers, and site leadership teams.
- Independent, well organised, and effective at managing multiple priorities under pressure, with a detail oriented, collaborative, and results driven mindset.
Please submit your resume in English if you are interested in this opportunity.
