3 дня назад
Assistant Engineer, Quality (Medical Technology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Assistant Engineer, Quality (Medical Technology): Supporting product and supplier quality for medical monitoring technologies with an accent on QMS maintenance, regulatory compliance, inspections, and CAPA. Focus on conducting quality investigations, managing nonconformities, supporting supplier improvement, and maintaining compliance with ISO 13485 and FDA QSR requirements.
Location: Pasir Gudang, Johor, Malaysia; on-site
Company
Masimo is a operating company that develops and produces medical monitoring technologies, sensors, patient monitors, and automation and connectivity solutions.
What you will do
- Perform product inspections, quality investigations, validation activities, and KPI monitoring.
- Support corrective and preventive action (CAPA) activities and manage nonconformities.
- Maintain QMS documentation, quality records, audits, and regulatory compliance.
- Support supplier quality activities, including supplier qualification, NCR/SCAR follow-up, and supplier improvement.
Requirements
- At least 1 year of experience in manufacturing or product quality, QMS, and/or supplier quality.
- Familiarity with ISO 13485 and FDA QSR requirements.
- Basic knowledge of quality tools and techniques.
- Ability to work in an office, laboratory, and manufacturing environment involving sitting, standing, walking, audits, testing, color recognition, and lifting up to 50 lbs.
- Daily computer use, a valid passport for international travel, and a valid driver’s license for local travel.
Nice to have
- Strong analytical, problem-solving, organizational, and documentation skills.
- Excellent attention to detail, communication, and teamwork skills.
- Ability to manage multiple tasks effectively in a fast-paced environment.
Culture & Benefits
- Full-time position within the Quality Department.
- Medical card, dental allowance, and optical allowance.
- Paid time off and broader employee benefit programs.
- Bonus eligibility of up to 10% of annual base salary, subject to applicable criteria and performance conditions.
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