Quality Assurance Professional
1 week ago
This role is responsible for providing high-quality assurance support within Cook Medical Europe Ltd. (CMEU). The primary responsibilities include maintaining the internal audit system, supporting software validation, handling non-conformance issues, and contributing to the Company's corrective and preventive action program.
This position reports directly to the Senior Manager, Quality Assurance.
Key Responsibilities- Maintain an active oversight of the CMEU Quality Management System (QMS) to ensure compliance with procedures, requirements, and best practices.
- Conduct in-depth internal audits of all aspects of the QMS against relevant regulations, working collaboratively with stakeholders to achieve zero non-conformances within CMEU.
- Develop and maintain a detailed knowledge of medical device regulations, guidance, and requirements relevant to Quality Assurance.
- Organize and manage site preparation and back rooms for regulatory and corporate audits.
- Provide Quality Assurance support to all areas of the QMS, ensuring compliance at all times.
- Bachelor's degree in Quality, Science, Engineering, or a related technical field.
- Minimum 4 years of experience working with ISO13485, ISO14971, FDA QSR, EU MDR, and other applicable regulations in the medical device industry.
- Certified Lead Auditor, preferably within the medical device industry.
- Excellent communication and interpersonal skills, with the ability to effectively communicate at all organizational levels.
- Demonstrable problem-solving skills, with a proactive approach to addressing quality-related issues.
- Strong attention to detail and organizational skills, with the ability to manage time effectively.
- Ability to travel on company business.
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