2 часа назад
Quality Auditor (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
Quality Auditor (Medical Devices): Executing internal audits and supporting the audit process for a medical technology organization with an accent on quality management systems, regulatory compliance, and audit finding lifecycle management. Focus on analyzing audit trends, identifying quality improvements, researching applicable standards, and ensuring compliance with FDA, ISO, and Malaysian medical device requirements.
Location: On-site in Pasir Gudang, Johor, Malaysia
Company
Medical technology operations develop monitoring technologies, sensors, patient monitors, and automation and connectivity solutions within a global life sciences and diagnostics organization.
What you will do
- Execute internal audit activities in accordance with company procedures.
- Maintain and support the audit process, including audit administration.
- Conduct audits, report findings, and monitor findings through completion.
- Assist with trend analysis related to audit observations.
- Identify and communicate opportunities to improve the quality management system.
- Research applicable regulations and standards to support ongoing compliance.
Requirements
- Bachelor’s or master’s degree in engineering, Quality Management, Life Sciences, or an equivalent combination of education and related experience.
- Expertise in FDA 21 CFR Part 820 (QSR), ISO 13485, SOR 98-282 CMDR, and the Malaysia Medical Device Authority Act 2012 (Act 738).
- Excellent oral and written communication skills.
- Strong organization and record-keeping skills.
- Ability to work with minimal supervision.
- Ability to work on-site in Pasir Gudang, Johor, Malaysia.
Culture & Benefits
- Culture focused on belonging, continuous improvement, innovation, and tangible impact.
- Health care programs and paid time off.
- Eligible for bonus or incentive pay of up to 10% of annual base salary, subject to eligibility and performance conditions.
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