
Medical Device Validation Specialist
1 week ago
This position oversees the validation program to guarantee conformity with regulatory requirements, quality standards and industry guidelines.
- Manage site equipment, utilities, processes and software validation to ensure compliance.
- Develop and maintain a validation master plan, project plans and schedules.
- Prepare and submit validation protocols and reports according to quality standards.
- Analyze and implement corrective actions for validation issues.
- Review and approve quality documents and test data.
- Coordinate validation, exception event and change control processes.
- Maintain track of validation equipment usage.
- Bachelor's degree in engineering or science.
- At least 3 years of experience in validation/quality assurance in medical device manufacturing.
- Strong knowledge of quality standards and regulatory requirements.
- Excellent communication, presentation and problem-solving skills.
- Able to work independently and as part of a team.
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