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Danaher

Makes tools for drug research and medical testing

Assistant Engineer - Quality

Inspection & Test +1Confirmed live in the last 24 hours
Full-timePasir Gudang, Johor, MalaysiaNo salary listed

About the Job

Requirements

  • A diploma or degree in Engineering or a related technical field is required.
  • Experience in manufacturing quality, product quality, Quality Management Systems (QMS), and/or supplier quality is required.
  • Familiarity with ISO 13485, FDA Quality System Regulation (QSR), and basic quality tools is required.

Responsibilities

  • 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 key performance indicators to identify improvement opportunities.
  • Investigate product nonconformances, customer complaints, returned products, and field issues to identify root causes and corrective actions.
  • Support validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), test method validation, sampling plans, and Gage Repeatability and Reproducibility (Gage R&R).
  • Work 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 Quality Management System in compliance with ISO 13485, FDA 21 CFR 820, CMDR, MDD 93/42 EEC, and internal procedures.

About the Company

Danaher

Makes tools for drug research and medical testing

Danaher makes instruments, tests and laboratory supplies for drug developers, researchers and clinicians, spanning the path from biological research to clinical patient diagnosis. Its businesses include Cytiva for drug manufacturing, SCIEX for chemical analysis and Beckman Coulter for laboratory testing, linking specialized tools across healthcare workflows. Customers use its equipment to study cells, produce biological medicines and analyze patient samples; the group earns money by selling instruments, reagents, software and support services through its operating companies. Danaher was established in 1984 and is headquartered in Washington, DC.

Company size
10,001+
Company stage
IPO
Headquarters
Washington, DC
Founded
1984

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