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1 час назад

Assistant Engineer, Quality

Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
Malaysia
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Assistant Engineer, Quality (Medical Technology): Ensuring end-to-end quality for medical monitoring products with an accent on inspections, nonconformance investigations, validation activities, and quality management systems. Focus on analyzing product defects, supporting CAPA and corrective actions, resolving reliability issues with engineering and production teams, and maintaining compliance with ISO 13485 and FDA requirements.

Location: On-site in Pasir Gudang, Johor, Malaysia

Company

Masimo, a hirify.global operating company, develops medical technology including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions.

What you will do

  • Perform and support incoming, in-process, and final inspections against product specifications and quality requirements.
  • Monitor product yield, defect trends, and quality KPIs to identify improvement opportunities.
  • Investigate product nonconformities, customer complaints, returned products, and field issues, identifying root causes and corrective actions.
  • Support validation activities, including IQ/OQ/PQ, test method validation, sampling plans, and Gage R&R.
  • Collaborate with engineering and production teams to resolve product performance and reliability issues.
  • Maintain quality records and support continuous improvement of the QMS.

Requirements

  • Diploma or degree in engineering or a related technical field.
  • Experience in manufacturing quality, product quality, QMS, and/or supplier quality.
  • Familiarity with ISO 13485, FDA QSR, and basic quality tools.
  • Ability to work on-site in Pasir Gudang, Johor, Malaysia.

Culture & Benefits

  • Work within hirify.global's continuous improvement system and a cross-functional quality team.
  • Healthcare programs and paid time off are included among the available benefits.
  • Eligible for bonus or incentive pay of up to 10% of annual base salary, subject to eligibility and performance conditions.

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