Sr. Engineer II, QARA (QMS)

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The Senior Engineer, QARA (QMS) is responsible for supporting the effective implementation and maintenance of the Quality Management System (QMS) in compliance with applicable standards and regulatory requirements, including ISO 9001, ISO 13485, FDA Quality Management System Regulation (QMSR). This role leads and supports document control, training, eQMS, audit, CAPA, and continuous improvement activities, working cross-functionally to strengthen QMS effectiveness and site compliance.

This position reports to the Senior Manager, Global QMS Document Control & Training and is part of the QARA team located in Singapore and will be an on-site role.

In this role, you will have the opportunity to:

• Lead and continuously improve the Quality Management System (QMS) to ensure compliance with applicable standards and regulations, including ISO 9001, ISO 13485, FDA Quality Management System Regulation (QMSR), and other relevant requirements.
• Manage QMS document control, training, and electronic quality systems, including document changes, controlled records, archival practices, QMS-related training, site eQMS administration, quality metrics and visual management
• Lead and support internal and external audits, including audit planning, readiness, coordination, execution, follow-up activities, gap remediation, and timely closure of audit actions to ensure ongoing compliance and inspection readiness.
• Support quality processes, including CAPA management, cross-functional investigations, solution implementation, effectiveness verification, status reporting, escalation activities, process guidance, and Non-Product Software Validation.
• Partner with cross-functional stakeholders to enhance QMS effectiveness and operational excellence, driving process standardization, continuous improvement initiatives, Kaizen events, and other related duties or ad hoc assignments as required.

The essential requirements of the job include:

• Diploma or bachelor’s degree in engineering, Quality Assurance, or a related field, with a minimum of 3 years of experience in a manufacturing environment, preferably instrument manufacturing.
• Working knowledge of Quality Management Systems (QMS) and applicable regulatory requirements, including ISO 9001, ISO 13485, and FDA Quality Management System Regulation (QMSR), with experience conducting or leading QMS audits and supporting audit readiness and follow-up activities.
• Experience with electronic Quality Management System (eQMS), document control, quality record management, and developing or improving procedures and work instructions to ensure QMS compliance.
• Strong written and verbal communication skills, with the ability to collaborate effectively across functions and organizational levels while working independently in a fast-paced environment.
• Highly organized and detail-oriented, with proficiency in Microsoft Office, Power BI, data analysis and statistical techniques.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel up to 5%, overnight, within territory (if necessary)

It would be a plus if you also possess previous experience in:

• Demonstrated experience working within ISO 9001 and/or ISO 13485 compliant quality systems.
• Proven expertise in Document Control management and continuous improvement of QMS processes.
• Clinical knowledge and an understanding of medical device operational environments.

SCIEX, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.