Manager, Quality

Radiometer; Pasir Gudang; On-site; MYR 180,000 - 260,000; Full time

Benefits offered by this job

Bonus up to 10%

Job summary

Masimo, a Danaher operating company, is seeking a QUALITY Manager to uphold the highest quality, regulatory, and compliance standards across manufacturing. This on-site role is based in Pasir Gudang, Johor and reports to the General Manager.

You will develop and maintain a robust QMS aligned with ISO 13485 and FDA guidelines, lead supplier audits, manage risk, and collaborate with R&D, manufacturing and regulatory authorities to embed quality throughout the product lifecycle.

Qualifications

• Bachelor’s or Master’s degree in engineering, quality management, life sciences, or related field.
• Extensive experience in quality management for medical device/pharma manufacturing.
• Strong knowledge of ISO 13485, FDA QSR, and EU MDR plus Six Sigma/Lean methods.

Responsibilities

• Develop and maintain an effective QMS compliant with ISO 13485 and FDA guidelines.
• Lead quality audits, supplier qualification, and risk management processes.
• Collaborate with R&D, manufacturing and regulatory authorities to embed quality across the product lifecycle.

Skills

Quality management

Regulatory compliance

Six Sigma

Lean

Team leadership

Analytical thinking

Education

Bachelor's or Master's 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.

The Manager, Quality is responsible in ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of the manufacturing process. This leadership position requires expertise in quality management systems, regulatory requirements, and continuous improvement methodologies. The Quality Manager is responsible for establishing and maintaining a culture of quality excellence while ensuring the safety and efficacy of medical products. This position reports to the General Manager 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: Develop, implement, and manage a robust quality management system (QMS) compliant with applicable regulations such as ISO 13485 and FDA guidelines. Stay current with medical device regulations, standards, and guidelines to ensure the company\'s products are compliant Oversee and perform quality audits, assessments, and inspections to ensure adherence to quality standards. Manage the qualification, assessment, and auditing of suppliers to ensure the quality of incoming materials and components. Implement risk management processes to identify, assess, and mitigate risks associated with product quality and safety. Define and monitor key quality metrics to assess the effectiveness of the QMS and manufacturing processes. Collaborate with R&D, manufacturing, engineering, and other departments to ensure quality considerations are integrated throughout the product lifecycle

The essential requirements of the job include: Bachelor’s or master’s degree in engineering, Quality Management, Life Sciences, or related field. Extensive experience in quality management within the medical device or pharmaceutical manufacturing industry. In-depth knowledge of relevant regulations and standards, such as ISO 13485, FDA QSR, and EU MDR. Strong experience with quality tools and methodologies (e.g., Six Sigma, Lean) to drive process improvement. Proven experience in managing and leading quality teams. Excellent problem-solving, analytical, and decision-making skills. Effective communication skills to interact with cross-functional teams and regulatory authorities. 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. 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.