Engineer, Quality

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The Engineer, Quality is responsible for providing technical input for quality engineering throughout the product manufacturing process. This position handles multiple projects through manufacturing of finished devices.

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:

• 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

The essential requirements of the job include:

• 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

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.

This job is also eligible for a comprehensive package of benefits and specifically phone allowance, 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.