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Quality Assurance Specialist
2 months ago
iO Associates - UK/EU is seeking a highly experienced Quality Engineer to join their team. The role will involve reviewing and creating requirements and specifications, validation protocols and reports, risk management documentation, and design change records. The ideal candidate will have in-depth knowledge of ISO 13485 and 21 CFR Part 820 Quality System Regulations. Key responsibilities include:
* Developing and implementing quality management systems
* Conducting risk assessments and creating risk management plans
* Collaborating with cross-functional teams to ensure compliance with regulatory requirements
The successful candidate will have:
* 5+ years of experience in a Quality Engineering role within the medical device industry
* Proficiency in using risk management tools and techniques in compliance with ISO 14971
* Strong understanding of quality management principles and regulatory requirements
If you are a motivated and detail-oriented Quality Engineer looking for a new challenge, please apply.