Senior Engineer, Product Quality

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The Senior Engineer, Product Quality is responsible forserving as the Product Quality Engineering (PQE) lead for assembly and test operations, ensuring effective resolution of product quality issues, compliance with Quality Management System (QMS) requirements, and adherence to global medical device regulations and standards. This role drives complex quality investigations, risk management, validation, and continuous improvement initiatives through cross-functional collaboration, data-driven analysis, and the application of risk-based methodologies to enhance product quality, manufacturing performance, and regulatory compliance throughout the product lifecycle.

This position reports to the Senior Manager, PQE, and is part of the Product Quality Engineering team located at the SCIEX Woodlands, Singapore site and will be an on-site role.

In this role, you will have the opportunity to:

• Serve as the PQE representative for assembly and test operations, ensuring timely reporting, escalation, disposition, in regards of driving resolution on product quality issues, while compliance with Quality Management System (QMS) requirements.
• Champion complex quality investigations and execution (e.g. NCMR, CAPA, Post Market escalations), leveraging structured problem-solving methodologies (e.g. 5why, 8D, Fishbone diagram, etc) and lead cross-functional collaboration to deliver sustainable quality and compliance outcomes.
• Drive continuous improvement of quality processes through analysis of quality trends, manufacturing performance, customer feedback, and KPI metrics to identify emerging risks, recurring issues, and propose opportunities for improvement.
• Demonstrated expertise in medical device risk management and validation, across product lifecycle, including the development and maintenance of Risk Management Files, PFMEA, Control Plans (PCP), process validation (IQ/OQ/PQ), and the application of risk-based decision-making in compliance with regulatory and quality system requirements.
• Ensure compliance with applicable regulatory and quality standards, including ISO 9001, ISO 13485, FDA 21 CFR Part 820, MDSAP requirements, and other relevant global regulations governing medical device products and manufacturing processes.

The essential requirements of the job include:

• Bachelor's degree in scientific or engineering discipline (mechanical, electrical, software/computer engineering expertise preferable) from four-year college or university and/or training or equivalent combination of education and experience.
• Minimum 3-5 years of experience in regulated environments with hands-on expertise in medical device risk management and the application of risk-based methodologies to product realization, manufacturing processes, quality systems, and continuous improvement initiatives.
• Exposure to and/or experience with verification and validation of Medical Devices in New Product Introductions.

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

• Hands-on experience in Risk Management as it relates to Medical Devices products and processes
• Exposure to and/or experience with verification and validation of Medical Devices in New Product Introductions.

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.

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.