Director of Group Quality - Sweden
Investigate product quality complaints from Markets, Production, Suppliers, and Design. Determine root cause of each complaint and work with appropriate departments to correct and prevent future occurences.
Investigate potential field actions/upgrades/recalls and propose appropriate action to CEO and Sr. VP Quality
Oversee product risk management and revise exsisting risk analysis based upon post market data
Issue Production Messages, and Assignments to address root cause solutions to product complaints
Serve as a resource for input to Design, Sourcing, Production, and Legal departments
Monitor product quality through pre and post market data and statistical reports
Educate organization as needed on relevant quality tools and techniques designed to improve product quality.
Develop a solid understanding of customer expectations.
Develop annual quality improvement plans for production units and suppliers intended to organize and improve quality efforts and results.
Support Group Sourcing with supplier corrective actions, and quality audits.
Assist in the development of a Group quality strategy that ensures compliance to all reguations and improves overall product quality
Provide regular reports of product quality issues ensuring proper visibility within the company
Track and report the total cost of poor quality
Develop business cases and justifications for quality improvement investments
Authority & Responsibilities:
Responsible for setting the standard of quality for product
Responsible for addressing significant quality issues within theGroup
Responsible for supporting Company Quality system strategy within the Group
Master of Science
Excellent knowledge of manuafacturing quality processes, design control and specifications, and supplier performance criteria ideally in the medical devices industry
At least 10 years experience in quality assurance or related
Experienced in running quality systems ideally for medical device manufacturing
Experienced in manufacturing quality processes and systems
Experienced in solving product quality issues and data analysis.