Job Summary
• Bachelor’s degree in Engineering, Science, or a related technical field.
• 5+ years of experience in Quality Engineering or Quality Management.
• Hands-on experience managing an ISO 9001-compliant QMS.
• Proven track record in internal/external audits, CAPA management, and delivering measurable quality improvements.
• Experience in semiconductor, capital equipment, or high-tech manufacturing environments preferred.
Key Responsibilities
- Own, govern, and continuously improve QMS processes to ensure scalability, consistency, and ISO 9001 compliance.
- Drive process standardization across sites and product lines.
- Manage controlled documentation and compliance requirements.
- Lead ISO certification, surveillance, and recertification audits; act as the primary interface with auditors and stakeholders.
- Strengthen audit readiness and close systemic compliance gaps.
- Drive continuous improvement initiatives through CAPA programs and root cause analysis.
- Apply advanced quality tools to resolve complex business and operational challenges.
- Define, monitor, and analyze QMS KPIs and performance metrics.
- Partner with Engineering, Operations, and Supply Chain to embed quality into daily operations.
- Influence decision-making by connecting quality outcomes to business performance.
Skill Requirements
- Strong knowledge of ISO 9001-compliant QMS, CAPA, internal audits, documentation control, and quality metrics.
- Expertise in quality methodologies such as 8D, FMEA, SPC, and 5 Whys.
- Analytical mindset with the ability to convert data into actionable insights.
- Excellent communication, stakeholder management, and influencing skills.
- Ability to work effectively in cross-functional and matrixed environments.
- Experience with ERP/QMS tools such as SAP Quality Module (preferred).
- ISO 9001 Lead Auditor, ASQ (CQE/CQA), or Six Sigma certifications preferred.