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
Perform and support incoming, in-process, and final inspections to ensure product compliance with specifications and quality requirements.
Monitor product yield, defect trends, and quality KPIs to identify improvement opportunities.
Conduct investigations on product nonconformance, customer complaints, returned products, and field issues to identify root causes and corrective actions.
Support validation activities including IQ/OQ/PQ, test method validation, sampling plans, and Gage R&R.
Work closely with engineering and production teams to resolve product performance or reliability issues.
Maintain product quality records, including inspection reports, validation documents, and product release data.
Support implementation, maintenance, and continuous improvement of the QMS in compliance with ISO 13485, FDA 21 CFR 820, CMDR, MDD 93/42 EEC, and internal procedures.
The essential requirements of the job include
Diploma/Degree in Engineering or related technical field.
Experienced in manufacturing quality, product quality, QMS, and/or supplier quality.
Familiar with ISO 13485, FDA QSR, and basic quality tools
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.
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