Engineer, Quality at Masimo

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

Benefits offered by this job

Phone allowance

Medical card

Dental allowance

Optical allowance

Job summary

Masimo, a Danaher operating company, seeks a Quality Engineer to assure conformance of processes and systems during manufacture and QC. The role involves leading problem solving, IQ/OQ/PQ activities and risk management to maintain product quality.

On-site in Malaysia, you will support NCR data generation and inspections, requiring a B.S. in Science or Engineering and relevant ISO 13485 experience. MBA or M.S. is a plus for advancement.

Qualifications

• B.S. in Science or Engineering required.
• M.S. in Science or Engineering or MBA preferred.
• Experience in quality engineering in a device manufacturing environment.
• Direct experience with ISO 13485 is essential.

Responsibilities

• Assure conformance of systems and processes during manufacture and quality control to applicable standards.
• Lead and participate in problem solving related to manufacturing and inspection.
• Participate in IQ/OQ/PQ activities and risk management to ensure product quality.
• Support quality compliance with data generation for NCR and inspections.

Skills

Quality engineering

Manufacturing experience

Regulatory compliance

Problem solving

Gage R&R

Education

B.S. in Science or Engineering

M.S. in Science or Engineering or MBA

Tools

IQ/OQ/PQ

Gage R&R

Job description

This Full time on site position offers great opportunities for career growth. 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.

Key Responsibilities

• 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

Essential Requirements

• 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

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 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.

Additional Benefits

• phone allowance
• medical card
• dental allowance
• optical allowance

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.