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Job Information

Director of Group Quality - Medical Devices

Information About this Role

Director of Group Quality - Sweden

Key Duties:

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

Education/Certification:

Master of Science

Required Knowledge:

Excellent knowledge of manuafacturing quality processes, design control and specifications, and supplier performance criteria ideally in the medical devices industry

Experience Required:

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.