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5 дней назад

Engineer, Incoming Quality (Medtech)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
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
Engineer, Incoming Quality (Medtech): Inspecting incoming materials and components for compliance with quality standards, specifications, and regulatory requirements with an accent on supplier quality, measurement systems, and medical-device documentation. Focus on managing non-conforming materials, resolving supplier quality issues, supporting audits and corrective actions, and driving continuous improvement in an onsite manufacturing environment.

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

Company

Masimo is a hirify.global operating company developing and producing medical monitoring technologies, sensors, patient monitors, and connectivity solutions.

What you will do

  • Inspect incoming materials and components against quality standards, specifications, and regulatory requirements.
  • Maintain inspection records, certificates of conformance, and quality documentation.
  • Manage non-conforming materials, corrective actions, and incoming quality issues.
  • Collaborate with suppliers and Quality teams to improve material quality and resolve problems.
  • Maintain inspection procedures, visual aids, physical samples, and calibration of inspection equipment.
  • Support quality-system activities, employee training, audits, and continuous improvement initiatives.

Requirements

  • At least 3 years of experience in incoming quality or a related quality role.
  • Experience in quality engineering, supplier quality, or manufacturing environments.
  • Hands-on measurement experience with hand tools, microscopes, and image measuring systems.
  • Good written and spoken English communication skills.
  • Strong communication, teamwork, analytical, problem-solving, and attention-to-detail skills.
  • Ability to work in office, laboratory, and manufacturing environments, including standing, walking, audits, testing, color recognition, and lifting up to 50 lbs.

Nice to have

  • Knowledge of root cause analysis, CAPA, risk management, and quality inspection techniques.
  • Proficiency in Microsoft Office.
  • Knowledge of ISO 13485, ISO 14971, IEC 60601-1, and FDA regulations.
  • ISO Internal Auditor certification and knowledge of statistical analysis.

Culture & Benefits

  • Culture focused on innovation, continuous improvement, belonging, and tangible impact in life sciences and medical technology.
  • Comprehensive benefits package including healthcare, paid time off, phone allowance, medical card, dental allowance, and optical allowance.
  • Eligible for bonus or incentive pay of up to 10% of annual base salary, subject to eligibility and performance conditions.
  • Daily computer use is required, along with a valid passport for international travel and a valid driver’s license for local travel.

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