**Senior Design Control Quality Engineer**
Vor 5 Tagen
We are seeking a highly skilled and experienced **Senior Design Control Quality Engineer** to join our team at Tandem Diabetes Care Switzerland Sàrl. As a key member of our quality assurance team, you will play a critical role in ensuring the development and delivery of high-quality medical devices that meet the highest regulatory standards.
Key Responsibilities- Design Control and Quality Assurance: Provide quality guidance and support for design control, product transfer to manufacturing, sustaining engineering, production, and quality system activities to ensure conformance to established specifications and risk reduction.
- Regulatory Compliance: Ensure that all products and processes comply with relevant regulatory requirements, including ISO 13485, 21CFR Part 820, and ISO 14971.
- Quality System Process: Support the development, implementation, and maintenance of quality system processes, including design control, change control, and corrective action.
- Technical Documentation: Develop, update, and review technical documentation, including design inputs/outputs, specifications, design reviews, and test methods.
- Collaboration and Communication: Work closely with cross-functional teams, including design, manufacturing, and quality assurance, to ensure seamless execution of quality-related activities.
- Education: Master's degree in Engineering, preferably Mechanical Engineering, Biomedical Engineering, or equivalent education and applicable work experience.
- Experience: 5 years' experience working as a Quality Engineer in a medical device, manufacturing, or regulated industry.
- Certifications: Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.
We offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package. If you are a motivated and experienced quality professional looking for a new challenge, please submit your application.
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