Engineer, Quality

Radiometer; Pasir Gudang; On-site; MYR 90,000 - 150,000; Full time

Job summary

Masimo, a Danaher operating company, seeks an Engineer, Quality to support quality engineering across the product manufacturing process in Pasir Gudang, Johor. The role reports to the Assistant Manager, Quality and is an on-site position within the Quality Department.

You will drive conformance to internal procedures and international standards such as FDA CFR 21 820, ISO 13485, and CMDR, while leading NCR, supplier issues, and IQ/OQ/PQ activities to ensure robust product quality.

Qualifications

• Bachelor or higher in science or engineering required.
• MS or MBA preferred for advanced roles.
• Experience in quality engineering in device manufacturing.
• Experience evaluating products to quality standards.
• Direct experience with ISO 13485.

Responsibilities

• Provide technical input for quality engineering throughout manufacturing.
• Lead problem solving for manufacture, inspection and test issues.
• Participate in IQ/OQ/PQ activities and risk management.
• Support quality compliance data generation for NCR and inspections.

Skills

Quality engineering

Regulatory compliance

Problem solving

Equipment testing

Education

B.S. in Science or Engineering

M.S. in Science or Engineering or MBA

Tools

Gage R&R

IQ/OQ/PQ

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 Engineer, Quality is responsible for providing technical input for quality engineering throughout the product manufacturing process. This position handles multiple projects through manufacturing of finished devices. This position reports to the Assistant Manager, Quality and is part of the Quality Department located in Pasir Gudang, Johor and will be an on‑site role.

In this role, you will have the opportunity to:

• Assure conformance of systems and processes during manufacture, and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) and other applicable international standards and regulations
• Leads and participates in problem solving activities related to manufacture and inspection and test, including NCR and supplier related issues
• Leads and/or participate in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations
• Ensures robust application of the quality system by supporting the quality compliance process including the generation of data for NCR, RI and in process inspections

The essential requirements of the job include:

• B.S. in Science or Engineering is required.
• M.S. in Science or Engineering, or an MBA, is preferred
• Experience in quality engineering including practical experience in a device manufacturing environment
• Experience in evaluating products to Product quality Standards
• Direct experience with ISO 13485
• Physical/Environment Requirements: Indoor role requiring standing/walking. Must follow safety procedures, use appropriate PPE, and operate only approved low‑risk tools.
• It would be a plus if you also possess previous experience in: Technical knowledge experience in electronic manufacturing

Bonuses / Incentive Pay Up to 10 % of annual base salary

This job is also eligible for bonus 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.

This job is also eligible for a comprehensive package of benefits and specifically phone allowance, medical card, dental allowance and optical allowance. Details regarding these benefits will be provided separately.

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.

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. Please read our Applicant Data Privacy Notice carefully here.