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Quality Assurance Specialist
2 months ago
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 compliance of our medical devices.
Key Responsibilities- Develop and implement quality management systems (QMS) to meet ISO 13485 standards
- Conduct risk management and internal audits to identify and mitigate potential risks
- Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics Engineers, and Software Engineers, to ensure quality and compliance
- Validate medical devices and ensure they meet regulatory requirements
- Develop and maintain documentation, including procedures, work instructions, and records
- Degree in a relevant field, such as Engineering, Science, or a related discipline
- Experience in quality assurance and regulatory compliance, preferably in the medical devices industry
- Knowledge of ISO 13485 standards and regulatory requirements, such as 21 CFR Part 820
- Strong analytical and problem-solving skills, with attention to detail and ability to work independently
- Excellent communication and collaboration skills, with ability to work effectively with cross-functional teams
We offer a competitive salary and benefits package, including shares/equity scheme, life assurance, pension, private healthcare, income protection insurance, and an employer discount scheme.
