Medical Devices Quality Engineer
1 week ago
Job Summary
We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our medical devices.
Key Responsibilities
- Develop and implement quality management systems to meet ISO 13485 standards
- Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics Engineers, and Software Engineers
- Conduct risk management and internal audits to ensure compliance with regulatory requirements
- Validate medical devices and implement corrective actions as needed
- Work closely with the Quality Assurance Manager to develop and implement quality policies and procedures
Requirements
- Relevant degree in a field such as Medical Devices, Biotechnology, or a related field
- Experience in quality assurance and regulatory compliance in the medical devices industry
- Knowledge of ISO 13485 standards and 21 CFR Part 820
- Excellent communication and problem-solving skills
What We Offer
- A competitive salary and benefits package
- The opportunity to work with a dynamic and growing company
- A chance to make a real impact in the medical devices industry
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