Senior QMS & Compliance Engineer (On-Site)

SCIEX

Singapore

On-site

SGD 90,000 - 120,000

Full time

13 days ago
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Job summary

SCIEX in Singapore is seeking a Senior Engineer, QARA (QMS) to support the implementation and maintenance of the Quality Management System in compliance with ISO 9001, ISO 13485 and FDA QMSR. You will lead document control, training, eQMS, audits and CAPA to strengthen site compliance.

You will partner with cross-functional teams to drive standardization and continuous improvement, ensuring readiness for inspections while advancing QMS effectiveness in a fast-paced manufacturing environment.

Qualifications

  • 3+ years in a manufacturing environment, preferably instrument manufacturing.
  • Experience with QMS and regulatory requirements ISO 9001/13485 and QMSR.
  • Experience with eQMS, document control, quality records, and procedures.
  • Strong communication across functions and ability to work independently.

Responsibilities

  • Lead and improve QMS to meet standards and regulatory requirements.
  • Manage QMS document control, training, and eQMS.
  • Lead and support audits, including planning, readiness, and closure.
  • Support CAPA, investigations, and trend analysis.
  • Collaborate with cross-functional teams to drive process improvements.

Skills

QMS experience
Audits
eQMS
Document control
CAPA
Continuous improvement
Data analysis
Power BI
MS Office

Education

Engineering or QA degree

Job description

SCIEX in Singapore is seeking a Senior Engineer, QARA (QMS) to support the implementation and maintenance of the Quality Management System in compliance with ISO 9001, ISO 13485 and FDA QMSR. You will lead document control, training, eQMS, audits and CAPA to strengthen site compliance.

You will partner with cross-functional teams to drive standardization and continuous improvement, ensuring readiness for inspections while advancing QMS effectiveness in a fast-paced manufacturing environment.

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