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Medical Device Quality Assurance Specialist
2 months ago
Quality Assurance Role for Medical Devices
We are seeking a highly skilled Quality Assurance Engineer to join our team at Newton Colmore Consulting. As a Quality Assurance Engineer, you will play a crucial role in ensuring the quality and compliance of our medical devices with ISO 13485 standards.
Key Responsibilities:
- Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics Engineers, Software Engineers, and other professionals to ensure quality and compliance of medical devices.
- Implement and maintain Quality Management Systems (QMS) to meet regulatory requirements.
- Conduct risk management, internal audits, and validation of medical devices to ensure compliance with regulatory standards.
- Develop and implement quality procedures and processes to ensure consistency and efficiency.
- Work closely with the Quality Assurance Manager to ensure alignment with company goals and objectives.
Requirements:
- Degree in a relevant field, such as Engineering, Physics, or a related discipline.
- Experience in Quality Assurance for medical devices, with knowledge of ISO 13485 and 21 CFR Part 820.
- Strong analytical and problem-solving skills, with attention to detail and ability to work in a fast-paced environment.
- Excellent communication and interpersonal skills, with ability to work effectively with cross-functional teams.
What We Offer:
- A competitive salary and benefits package.
- The opportunity to work with a dynamic and growing company in the medical devices industry.
- A chance to develop your skills and expertise in Quality Assurance for medical devices.
