The QA Specialist will assist in developing, implementing and maintaining the company’s Quality Management System (QMS) with a drive and passion for continuous improvement.

The QA Specialist must have appropriate training and professional experience to work with the following activities. The position is located at the CareDx AB office in Stockholm. Travel may be requested, but very seldom.

Responsibilities include but not necessarily limited to:

• Review QC testing data and software development testing prior to final release
• Review laboratory and equipment records
• Conduct Product lot release
• Issue, review and approve quality documents
• Be the Trainer to company personnel when required
• Participate in internal audits
• Identify non-conformances, corrective and preventive actions
• Manage and verify the implementation of corrective and preventive actions
• Advise company personnel on all matters pertaining to the quality of company operations in compliance with quality requirements. This includes guidance in product design and development, risk assessment and production.
• Assist the Senior QA Manager in reporting to senior management on the performance of the QMS and identifying areas of improvement.
• Appointed as Process leader as defined in the individual “körkort”.

Competence requirements:

• Bachelor level (or higher) in a degree in Medical Science or equivalent
• Relevant experience from laboratory medical testing, research and development or medical device (or equivalent experience)
• Experience quality system according to ISO 13485
• Experience in conducting process and product risk assessments in accordance with applicable standards and regulations
• Experience of working in a regulated medical device (or equivalent) environment (minimum 5 years) with at least 2 years in a QC/QA role

Language:

• Excellent knowledge in Swedish and English.

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