Quality Assurance Specialist
3 days ago
CareDx, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team in Stockholm. As a key member of our Quality Management System (QMS) team, you will be responsible for developing, implementing, and maintaining our QMS with a focus on continuous improvement.
The ideal candidate will have a strong background in medical science, laboratory testing, and quality system implementation. Experience in conducting process and product risk assessments, as well as working in a regulated medical device environment, is highly desirable.
Key Responsibilities- Review and approve quality documents, including product lot release and laboratory records
- Conduct internal audits and identify non-conformances, corrective and preventive actions
- Manage and verify the implementation of corrective and preventive actions
- Provide guidance on quality requirements and advise company personnel on all matters pertaining to the quality of company operations
- Assist the Senior QA Manager in reporting to senior management on the performance of the QMS and identifying areas of improvement
- Bachelor's degree in Medical Science or equivalent
- Relevant experience from laboratory medical testing, research and development, or medical device (or equivalent experience)
- Experience with quality system implementation according to ISO 13485
- Excellent knowledge of Swedish and English
CareDx, Inc. offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to providing a safe and healthy work environment, and we are an equal opportunities employer.
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Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Specialist
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