20 часов назад
Engineer QA (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Engineer QA (Medical Devices): Ensuring the quality of medical devices across supplier processes and finished products with an accent on standards compliance, verification, auditing, and supplier quality improvement. Focus on root cause investigations, CAPA implementation, product and process validation, and reducing product rejections and customer complaints.
Location: Nairobi, Kenya
Company
develops and supplies medical devices while coordinating quality activities with suppliers and teams in the United States and China.
What you will do
- Provide quality guidance to QA, project management, sourcing, suppliers, and other functional teams.
- Verify in-process and finished medical device products against company and international standards.
- Define product testing parameters and perform process, production, and quality control audits.
- Manage supplier quality projects involving product design changes, quality improvement, and critical product performance monitoring.
- Investigate customer complaints, identify root causes, implement CAPAs, and verify that corrective solutions remain effective.
- Validate and optimize supplier production parameters while identifying product and process improvements and cost savings.
Requirements
- Bachelor’s degree in Mechanical, Materials, Industrial, or medical device-related engineering.
- At least 3 years of engineering experience; project management experience is preferred.
- Experience with process control, quality control, and quality system requirements such as ISO 13485 or ISO 9001.
- Ability to interpret product specifications and engineering drawings and identify improvements in products, processes, and documentation.
- Proficiency with AutoCAD or SolidWorks, Microsoft Word, Microsoft Excel, Adobe, and email.
- Excellent English speaking, reading, and writing skills; frequent travel availability required.
Culture & Benefits
- Health insurance, life and disability insurance, paid time off, and 401(k) contributions for eligible employees working 30 or more hours per week on average.
- Employees working fewer than 30 hours per week receive 401(k) contributions and access to the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
- Inclusive workplace focused on belonging, diversity, career growth, and access to tools and resources for effective work.
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