Assistant Engineer, Quality

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 Masimo, one of Danaher’s 15+ operating companies, our work saves lives—and we’re 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. Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others. Learn about the Danaher Business System which makes everything possible. The Assistant Engineer, Quality is responsible for ensuring end-to-end quality across the product lifecycle, including product quality assurance, supplier quality performance, and maintenance of the Quality Management System (QMS). This role collaborates with cross-functional teams to monitor product performance, manage nonconformities, support CAPA activities, ensure compliance with regulatory requirements, and drive continuous improvements This position reports to the Assistant Manager, Quality and is part of the Quality team located in Pasir Gudang, Johor and will be an on-site role. In this role, you will have the opportunity to: Perform and support incoming, in-process, and final inspections to ensure product compliance with specifications and quality requirements. Monitor product yield, defect trends, and quality KPIs to identify improvement opportunities. Conduct investigations on product nonconformance, customer complaints, returned products, and field issues to identify root causes and corrective actions. Support validation activities including IQ/OQ/PQ, test method validation, sampling plans, and Gage R&R. Work closely with engineering and production teams to resolve product performance or reliability issues. Maintain product quality records, including inspection reports, validation documents, and product release data. Support implementation, maintenance, and continuous improvement of the QMS in compliance with ISO 13485, FDA 21 CFR 820, CMDR, MDD 93/42 EEC, and internal procedures. The essential requirements of the job include: Diploma/Degree in Engineering or related technical field. Experienced in manufacturing quality, product quality, QMS, and/or supplier quality. Familiar with ISO 13485, FDA QSR, and basic quality tools Masimo, 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. Bonus / Incentive Pay Up to 10% of annual base salary. This job is also eligible for bonus / incentive pay. This is the target earnings as % of base annual salary, subject to objective eligibility criteria and performance conditions as set out in the applicable scheme terms and conditions. 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.