5 дней назад
Engineer, Incoming Quality (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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 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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