Quality Auditor

Radiometer; Pasir Gudang; On-site; MYR 60,000 - 100,000; Full time

Benefits offered by this job

Bonus up to 10% of base salary

Job summary

Masimo, a Danaher operating company, seeks a Quality Auditor to execute internal audits and manage the audit lifecycle at our Pasir Gudang site in Johor. Responsibilities include supporting audits, analyzing trends, and driving improvements in the quality management system.

The ideal candidate will have strong regulatory knowledge, excellent communication, and the ability to work with minimal supervision in a on-site setting.

Qualifications

• Bachelor’s or master’s degree in engineering, Quality Management, Life Sciences, or an equivalent combination of education and related experience.
• Expertise in FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR; Malaysia Medical Device Authority Act 2012 (Act 738).
• Excellent communication skills and the ability to express ideas both orally and in written form.

Responsibilities

• Maintain and support Audit processes.
• Assist with trend analyses related to audits (e.g. types/number of observations).
• Identify and communicate opportunities to improve the quality management system.

Skills

Auditing experience

Quality systems

Regulatory knowledge

Communication skills

Organizational skills

Education

Bachelor's or Master's degree in Engineering/Quality Management/Life Sciences

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.

Role

The Quality Auditor is responsible for the execution of Audit activities and assisting with the administration of the Internal Audit process in accordance with Company procedures. This position will interface with individuals at all levels of the organization to conduct audits at specified intervals and report audit findings. This position will facilitate and monitor the life-cycle of audit findings until completion. 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:

• Maintain and support Audit process
• Assist with trend analyses related to audits (e.g. types/number of observations)
• Identify and communicate opportunities to improve the quality management system
• Research applicable regulations and standards to ensure the Company’s ongoing compliance
• Other duties or special projects as assigned

Requirements

The essential requirements of the job include:

• Bachelor’s or master’s degree in engineering, Quality Management, Life Sciences, or an equivalent combination of education and related experience.
• Expertise in FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR; Malaysia Medical Device Authority Act 2012 (Act 738.
• Excellent communication skills and the ability to express ideas both orally and in written form.
• Well organized and accustomed to maintaining excellent records.
• Ability to work with minimal supervision.

Company culture & benefits

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 us

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.