Senior Quality Systems Engineer – QMS (Life Sciences)

Danaher Corporation; Singapore; On-site; SGD 95,000 - 130,000; Full time

Benefits offered by this job

Danaher Benefits Info

Job summary

SCIEX, a Danaher operating company, is seeking a Senior Engineer, QARA (QMS) in Singapore. You will lead the Quality Management System implementation, maintenance and cross-functional strengthening to ensure ISO 9001/13485 and FDA QMSR compliance, including audits, CAPA and training.

You will report to the Senior Manager, Global QMS Document Control & Training, and work on-site in Singapore with opportunities to influence site-wide QMS effectiveness.

Qualifications

• 3+ years in a manufacturing environment, preferably instrument manufacturing.
• Working knowledge of QMS and regulatory requirements (ISO 9001, ISO 13485, FDA QMSR).
• Experience with eQMS, document control, quality records and procedures.
• Strong written and verbal communication across functions and levels.
• Proficient in Microsoft Office; knowledge of Power BI and data analysis is a plus.

Responsibilities

• Lead and support internal and external audits, including planning, readiness, execution and closure.
• Manage QMS document control, training, eQMS, CAPA and continuous improvement activities.
• Collaborate with cross-functional teams to strengthen QMS effectiveness and site compliance.
• Develop or improve procedures and work instructions to ensure QMS compliance.
• Provide quality guidance and monitor metrics, escalation and status reporting.

Skills

QMS knowledge

Auditing

eQMS

Document control

Power BI

Data analysis

MS Office

Cross-functional collaboration

Education

Diploma or Bachelor's in Engineering/QA

Tools

eQMS software

Job description

SCIEX, a Danaher operating company, is seeking a Senior Engineer, QARA (QMS) in Singapore. You will lead the Quality Management System implementation, maintenance and cross-functional strengthening to ensure ISO 9001/13485 and FDA QMSR compliance, including audits, CAPA and training.

You will report to the Senior Manager, Global QMS Document Control & Training, and work on-site in Singapore with opportunities to influence site-wide QMS effectiveness.