5 дней назад
Engineer, Quality (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Engineer, Quality (Medical Devices): Ensuring quality systems and manufacturing processes conform to FDA CFR 21 820, ISO 13485, CMDR, and other applicable standards with an accent on quality control, validation, and manufacturing compliance. Focus on solving NCR and supplier issues, leading IQ/OQ and PQ activities, validating test methods, conducting Gage R&R studies, and managing product quality risks.
Location: On-site in Pasir Gudang, Johor, Malaysia
Company
Masimo is a operating company that develops and manufactures medical monitoring technologies, sensors, patient monitors, and automation and connectivity solutions.
What you will do
- Provide technical quality engineering input throughout the manufacturing process for finished medical devices.
- Ensure manufacturing systems, processes, and quality control activities conform to internal procedures and applicable regulations.
- Lead and participate in problem-solving activities involving manufacturing, inspection, testing, NCRs, and supplier issues.
- Lead or support IQ/OQ and PQ activities, test sample size selection, test method validation, Gage R&R studies, and risk management.
- Generate quality data for NCRs, RI, and in-process inspections while supporting the quality compliance process.
Requirements
- Bachelor’s degree in Science or Engineering is required.
- Experience in quality engineering within a device manufacturing environment.
- Experience evaluating products against product quality standards.
- Direct experience with ISO 13485.
- Ability to work indoors while standing or walking and follow safety procedures and PPE requirements.
Nice to have
- Master’s degree in Science or Engineering or an MBA.
- Technical knowledge and experience in electronic manufacturing.
Culture & Benefits
- Health care program and paid time off.
- Phone allowance, medical card, dental allowance, and optical allowance.
- Eligibility for bonus pay of up to 10% of annual base salary, subject to applicable criteria and performance conditions.
- Continuous improvement culture supported by the Business System.
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