Assistant Engineer, Quality

Radiometer; Pasir Gudang; On-site; MYR 50,000 - 70,000; Full time

Benefits offered by this job

Bonus up to 10% of annual base salary

Medical, dental, and optical benefits

Job summary

Masimo, a Danaher operating company, is looking for an Assistant Engineer, Quality to join the Pasir Gudang, Johor site. You will be responsible for product and supplier quality, maintaining the QMS, CAPA, regulatory compliance, and continuous improvement.

This is an on-site role reporting to the Assistant Manager, Quality within the Quality Department. The role requires at least 1 year in manufacturing or product quality and familiarity with ISO 13485 and FDA QSR requirements.

Qualifications

• Familiar with ISO 13485 and FDA QSR requirements.
• Basic knowledge of quality tools and techniques.
• Minimum 1 year of experience in manufacturing or product quality, QMS, or supplier quality.

Responsibilities

• Perform product inspections, quality investigations, validation, KPI monitoring, and CAPA support.
• Maintain QMS documentation, quality records, audits, and regulatory compliance.
• Support supplier quality activities, including qualification, NCR/SCAR follow-up, and supplier improvement.

Skills

Quality

Investigations

CAPA

Education

Bachelor's degree in Engineering/Quality

Tools

QMS familiarity

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 product and supplier quality, QMS maintenance, CAPA, regulatory compliance, nonconformity management, and continuous improvement. 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:

• Perform product inspections, quality investigations, validation, KPI monitoring, and CAPA support.
• Maintain QMS documentation, quality records, audits, and regulatory compliance.
• Support supplier quality activities, including qualification, NCR/SCAR follow-up, and supplier improvement.

The essential requirements of the job include:

• Minimum 1 year of experience in manufacturing or product quality, QMS, and/or supplier quality.
• Familiar with ISO 13485 and FDA QSR requirements.
• Basic knowledge of quality tools and techniques.

Physical/Environment Requirements:

• Office, laboratory, and manufacturing role requiring frequent sitting, standing, walking, audits/testing, color recognition, and lifting up to 50 lbs.
• Requires daily computer use, a valid passport for international travel, and a valid driver’s license for local travel.

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

• Strong analytical, problem-solving, organizational, and documentation skills with excellent attention to detail.
• Good communication and teamwork skills, with the ability to manage multiple tasks effectively in a fast-paced environment.

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.

Compensation

• Bonus / 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 medical card, dental allowance and optical allowance.

Details regarding these benefits will be provided separately.

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. Please read our Applicant Data Privacy Notice carefully here.