Quality Systems Engineer II QMS & Compliance

SCIEX; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

SCIEX, a Danaher operating company, seeks a Senior Engineer, QARA (QMS) to implement and maintain ISO 9001/13485 and FDA QMSR compliant systems at our Singapore site. You will manage document control, training, eQMS, and CAPA processes while driving continuous improvement and audit readiness.

You will partner with cross-functional teams to enhance QMS effectiveness, report quality metrics, and ensure regulatory compliance in a fast-paced manufacturing environment.

Qualifications

• Bachelor's or Diploma in engineering or QA with 3+ years in manufacturing.
• Experience with QMS standards ISO 9001/13485 and FDA QMSR.
• Experience with electronic quality management systems (eQMS), document control, and quality-record management.
• Strong written and verbal communication across functions and levels.
• Detail-oriented, highly organized, proficient in MS Office and data analysis.

Responsibilities

• Lead and support the QMS implementation and continuous improvement efforts.
• Oversee document control, training, eQMS administration, audits, CAPA and cross-functional investigations.
• Coordinate internal and external audits, audit readiness and corrective actions.
• Drive process standardization and Kaizen-like improvements across the site.
• Collaborate with cross-functional stakeholders to strengthen QMS performance.

Skills

QMS knowledge

Audit leadership

Cross-functional collaboration

Communication

Data analysis

MS Office

Education

Bachelor's degree in engineering or quality assurance

Tools

eQMS

Document control systems

Power BI

Job description

SCIEX, a Danaher operating company, seeks a Senior Engineer, QARA (QMS) to implement and maintain ISO 9001/13485 and FDA QMSR compliant systems at our Singapore site. You will manage document control, training, eQMS, and CAPA processes while driving continuous improvement and audit readiness.

You will partner with cross-functional teams to enhance QMS effectiveness, report quality metrics, and ensure regulatory compliance in a fast-paced manufacturing environment.