Senior Design Quality Assurance Expert
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Job Description
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Responsibilities:
- Provides strategic quality leadership within cross-functional teams
- Applies design controls, risk management, and quality standards (FDA QSR, ISO, IEC)
- Acts as a key bridge between software development, product management, regulatory, and quality teams
- Supports document management, change control, product release activities, and complaint handling processes
- Serves as a subject matter expert during audits, inspections, design reviews, and milestone reviews
- Identifies potential compliance risks, proposes mitigation strategies, and drives resolution of quality issues
- Builds strong relationships with internal and external partners
Requirements:
- 5+ years of professional experience in Quality Assurance within regulated environments
- Strong expertise in software quality engineering and design controls
- Proven experience applying risk management methodologies (ISO 14971)
- Solid knowledge of global regulatory standards
- Experience supporting documentation management systems, change control, product release processes, and complaint handling
- Hands-on experience participating in audits, inspections, design reviews, and milestone reviews
- Practical experience working in agile development environments (Scrum, Kanban)
- Strong technical understanding of software development lifecycles, systems engineering, and associated toolchains
- Fluency in English
Benefits:
- Salary package based on your profile
- Permanent Contract
- Learning & Development
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