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Cordis is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our Quality Assurance department, you will be responsible for investigating customer complaints, analyzing product failures, and implementing corrective and preventive actions to ensure compliance with regulatory requirements.
Key Responsibilities- Investigate and analyze customer complaints to identify root causes of product failures
- Develop and implement corrective and preventive actions to prevent future failures
- Collaborate with cross-functional teams, including Engineering and Manufacturing, to resolve product-related issues
- Conduct product history reviews and evaluations to determine the root cause of failures
- Develop and maintain documentation of investigations, including audit observations and CAPA actions
- Participate in Quality Assurance operations and management meetings to present complaint trending analysis
- Stay up-to-date with regulatory requirements and industry standards
- Bachelor's degree in a related field, such as Engineering or Quality Assurance
- 4 years of experience as a Quality Engineer or in a related field
- Excellent written and oral communication skills
- Problem-solving skills and analytical thinking
- Ability to work independently and as part of a team
- Quality Auditor/Quality Engineer certification is desirable
- Experience in the medical device industry
- Knowledge of materials analysis and characterization
- Experience with laboratory equipment and testing