Global Supplier Quality Manager

Position Summary

This position works with suppliers to resolve specific quality issues and provide quality control expertise. The role involves facilitating corrective actions with suppliers, monitoring their CAPA investigations, and ensuring effectiveness of corrective actions taken. This role also facilitates supplier audits and technical meetings to monitor and assess supplier process capability and quality systems, as well as verification of corrective actions of supplier quality issues. Of key importance in this role is the management and monitoring of overall supplier performance for supplier selection, approval, and continuous improvement.

Primary Responsibilities

• Develop and maintain policies, procedures, and methods in support of the company’s quality policy, ISO 13485, and FDA requirements.
• Maintain and facilitate the NCM/CAPA processes for supplier nonconformances.
• Facilitate the maintenance of the Nonconformance (NCM) and Corrective Action (CA) modules to ensure compliance.
• Coordinate the “Supplier Selection and Approval” process for new suppliers and maintain quality records for existing suppliers.
• Oversee the Supplier Quality Management process including quality review of new and existing suppliers, corrective and remedial actions, process control assessments and general metrics. Ensure that supplier requirements are developed via material specifications.
• Define appropriate statistical methods to detect reoccurring quality problems. Provide reporting of quality issues to appropriate management and company personnel.
• Facilitate audit schedule and conduct supplier audits per defined procedure. Monitor quality audit results with supplier quality metrics. Assist suppliers in continuous improvement and development projects.
• Train staff and other company associates as required.
• Manage appropriate quality projects as required.
• Define, develop and implement appropriate supplier quality control processes.
• Set goals and objectives for the Global Supplier Quality Department.

Basic Qualifications

Education

• BS in Engineering or equivalent experience

Experience

• 5 years in a technical position

Preferred Qualifications

• Experience in quality management systems, problem solving methodologies, and continuous improvement.
• Ability to interface with customer and supplier base on quality related issues.
• Ability to interface with management as well as production personnel.
• Strong organizational, communication and influencing skills.
• Strong sense of urgency and ownership
• Strong organizational skills.

Working Conditions

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 10lbs.

Special Requirements

• Ability to travel (US and internationally)
• Ability to work evenings and/or weekends