Quality Assurance Specialist
3 days ago
Job Summary
iO Associates - UK/EU is seeking a highly experienced Quality Engineer to join our team. As a Quality Engineer, you will be responsible for reviewing and creating requirements and specifications, validation protocols and reports, risk management documentation, and design change records.
Key Responsibilities
- Develop and implement quality systems and processes to ensure compliance with ISO 13485 and 21 CFR Part 820 Quality System Regulations
- Collaborate with cross-functional teams to identify and mitigate risks associated with medical device development
- Conduct root cause investigations and implement corrective actions to address non-conformities
- Develop and maintain validation protocols and reports to ensure compliance with regulatory requirements
- Support the development of design change records and change control processes
Requirements
- 5+ years of experience in a Quality Engineering role within the medical device industry
- In-depth knowledge of ISO 13485 and 21 CFR Part 820 Quality System Regulations
- Proficient in using risk management tools and techniques in compliance with ISO 14971
- Strong analytical and problem-solving skills
- Excellent communication and collaboration skills
What We Offer
iO Associates - UK/EU offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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