Senior Engineer, Product Quality

Radiometer; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

SCIEX in Singapore is seeking a Senior Engineer, Product Quality to lead PQE for assembly and test operations, driving timely resolution of product quality issues and ensuring QMS compliance. You will lead complex investigations (NCMR, CAPA) and risk assessments, applying structured problem solving and data-driven improvements across the product lifecycle.

This on-site role reports to the Senior Manager, PQE at the Woodlands site, collaborating across functional teams to meet global quality

Qualifications

• Bachelor's degree in scientific or engineering discipline.
• Minimum 3-5 years in regulated environments with medical device risk management experience.
• Exposure to verification/validation of Medical Devices in NPD.

Responsibilities

• Serve as PQE lead for assembly and test operations; ensure timely reporting and escalation of quality issues.
• Lead complex quality investigations (NCMR, CAPA, post-market) using structured problem-solving.
• Drive continuous improvement via quality trend analysis, KPI review, and risk-based decision-making.
• Ensure compliance with ISO 9001, ISO 13485, and FDA 21 CFR Part 820 in manufacturing.
• Collaborate across functions to improve product quality and regulatory compliance.

Skills

Quality leadership

Risk management

Cross-functional collaboration

CAPA

NCMR

Data analysis

Education

Bachelor's degree in engineering

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At SCIEX, one of Danaher's 15+ operating companies, our work saves lives—and we are all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

As part of SCIEX, you will help to influence life changing research and outcomes, while accelerating your potential. For more than 50 years, we have been empowering our customers to solve the most impactful analytical challenges in quantitation and characterization through ground-breaking innovation and outstanding reliability and support. You will be part of a winning team, enabled by DBS, that is passionate about helping life science experts around the world get to answers they can trust. Learn about the Danaher Business System which makes everything possible.

The Senior Engineer, Product Quality is responsible for serving 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. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world's most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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