Vice President of Quality

Summary:

A leading medical device company based in Minneapolis, MN, is in search of a Vice President of Quality. This role focuses on cultivating a culture of Quality and Continuous Improvement throughout the organization by ensuring adherence to Quality System standards.

The company, known for its innovative approach to medical contract manufacturing and expertise in intricate materials transformation for essential components used in diagnostics, wearable technologies, and electronic devices, is specifically seeking candidates with the following qualifications:

Key Responsibilities

• Provide strategic direction and leadership for quality, risk management, and production departments.
• Influence quality integration in new product development and corporate goals.
• Promote organizational adoption of product lifecycle management tools.
• Foster a robust quality culture within the business area.
• Ensure compliance with Quality Management System standards (ISO 13485:2003, ISO 14971, FDA).
• Direct quality processes to meet customer and regulatory requirements.
• Collaborate with various departments to ensure compliance with Quality System design controls.
• Oversee completion of internal and external audit actions.
• Establish and track corrective and preventive actions.
• Maintain and review QA documentation for regulatory compliance.
• Implement effective training programs for quality system awareness and compliance.
• Monitor and report Quality metrics.
• Develop an efficient departmental structure and budget.
• Manage recruitment, training, and performance of employees.

Minimum Qualifications

Education

• Technical degree and 10 years of experience or a bachelor’s degree and equivalent experience.

Experience

• 10 years in Quality, specifically the medical device industry.
• Experience in quality systems development, management, and auditing.
• Experience with various Quality activities and interfacing with regulatory agencies.
• Supervisory and budget management experience in a developing company.
• Preferred: Experience in start-up or small company environments, establishing and growing Quality departments, ISO certification, quality management, and working with Class 1 and 2 medical devices.