Sr Engineer, Quality

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

Benefits offered by this job

Bonus up to 10%

Job summary

Masimo, part of the Danaher family, is seeking a Sr Engineer, Quality to ensure product quality, regulatory compliance, and continuous improvement in Pasir Gudang, Johor. This on-site role acts as a liaison among design, production, suppliers, and customers to uphold stringent quality standards.

The role involves QA activities across product development through manufacturing, CAPA/ NCR handling, and DHR/DMR documentation, with exposure to GMP and FDA 21 CFR Part 820.

Qualifications

• Associate’s or Bachelor’s degree in Life Sciences, Engineering, Quality Assurance, or a related field.
• Experience with GMP and FDA 21 CFR Part 820 compliance is highly preferred.
• Strong root-cause investigation and corrective/preventive action capability.
• Working knowledge of DHR/DMR and quality system documentation.

Responsibilities

• Ensure product quality, regulatory compliance, and continuous improvement across manufacturing and engineering processes.
• Lead problem solving related to design, manufacture and inspection and test including CAPA and NCR.
• Coordinate with design, production, suppliers and customers to uphold quality standards.
• Review Device History Records and ensure proper documentation meets specs and regulatory requirements.
• Apply statistical tools (e.g., Minitab) to monitor and improve processes.

Skills

Quality assurance

GMP compliance

Root cause analysis

CAPA

Education

Bachelor's degree in Life Sciences or related field

Tools

Minitab

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 Sr Engineer, Quality is responsible for ensuring product quality, regulatory compliance, and continuous improvement across manufacturing and engineering processes. This position will handle multiple projects from product inception, development, through manufacture and customer use. The incumbent provides a key role to ensure products meet defined quality and safety standards, and worldwide regulatory requirements. The Senior Quality Engineer acts as a key liaison between design, production, suppliers, and customers to uphold quality standards and ensure customer satisfaction. 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:

• Assist Quality Manager on quality assurance and product quality.
• Supports new product development and product manufacturing through the application of quality engineering tools
• Assure conformance of systems and processes during the development, manufacture, and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) MDD 93/42 EEC and other applicable international standards and regulations
• Leads and participates in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues
• Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution.
• Review and verify completeness and accuracy of Device History Records (DHRs) to ensure all manufacturing, inspection, and testing activities are properly documented and meet product specifications and regulatory requirements
• Develops and manages programs that monitor, predict, or regulate research and development, manufacturing, and inspection activities. This may be accomplished through the application of statistical tools such as Minitab and/or SQC pack.

The essential requirements of the job include:

• Associate’s or Bachelor’s degree in Life Sciences, Engineering, Quality Assurance, or a related field.
• Experienced in manufacturing, quality assurance, or document control.
• Experience with Good Manufacturing Practices (GMP) and/or FDA 21 CFR Part 820 compliance is highly preferred.
• Root Cause Investigation, failure analysis, root cause verification and developing robust corrective and preventive actions.
• Working knowledge of Device History Records (DHR), Device Master Records (DMR), and quality system documentation.
• Strong attention to detail and ability to spot inconsistencies or missing documentation.
• Direct experience in quality system audits.

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.

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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