Quality Assurance Specialist
6 days ago
Quality Lab Associate
Marion, NC
Duration: 2 Months
Position Summary
The deviation owner leads the investigation of deviations that occur in operations and is responsible for authoring the investigation summary report. Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of Product, product impact, root cause and corrective and preventive actions. Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations. Manage several investigations at a time.
Job Responsibilities
Determine Product, product impact, root cause and corrective actions for deviations from
manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation.
Conduct personnel interviews to determine root cause of the deviation.
Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate.
Required Education and Experience
Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with 2-3 years of experience in root cause evaluation, interpreting regulations and quality systems. Minimum of 5-8 years of experience in Manufacturing Operations and or Quality, or related field in the medical products industry.
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