Senior Quality Assurance Specialist
2 weeks ago
Responsibilities:
- Manage and control Quality Management System (QMS) processes in general and specifically risk management, design controls and transfer to production activities.
- Write, review and approve quality procedures and work instructions.
- Collaborate with cross-functional teams to ensure quality standards throughout the product lifecycle.
- Maintain a comprehensive understanding of quality and regulatory requirements, with a focus on ISO 13485 compliance.
- Participate in external audits.
Requirements
- At least 5 years of relevant experience in a QA position within the medical device industry.
- First degree in a relevant science or engineering subject.
- Experience in risk management and design controls.
- Demonstrate meticulous attention to detail in all QA-related tasks.
- Strong teamwork skills to drive quality initiatives.
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