Director Global Quality Jobs

Our client, a mid-sized, successful medical device firm, is working to produce innovative medical device with multiple products in pipeline from pre-clinical to the commercialization stage.

As the Global Quality Director, you will play a crucial role in ensuring the highest level of quality and regulatory compliance across all our global operations. You will be responsible for driving a culture of excellence in quality throughout the organization, overseeing quality systems and processes, and ensuring compliance with applicable regulations and standards. This is a senior leadership position that requires strategic thinking, strong leadership skills, and a deep understanding of quality management in the medical device industry.

The Global Quality Director will:

• Design and implement effective quality systems and processes to support product development, manufacturing, and post-market activities.
• Foster a culture of collaboration, accountability, and continuous learning.
• Develop and maintain a comprehensive understanding of relevant regulations, such as FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other applicable guidelines.
• Recruit, train, and develop a skilled and motivated quality organization.
• Implement and maintain a robust regulatory compliance program across all sites and functions.
• Provide leadership, coaching, and guidance to the quality team members.
• Stay abreast of global regulatory requirements and changes in quality standards for medical devices.

The Global Quality Director has the following qualifications:

• Strong leadership skills with the ability to influence and engage stakeholders at all levels of the organization.
• Exceptional communication and presentation skills, with the ability to effectively convey complex concepts to diverse audiences.
• Bachelor's degree in engineering, life sciences, or a related field. Advanced degree is a plus.
• Excellent problem-solving and analytical skills, with a data-driven approach to decision making.
• Deep knowledge and understanding of global quality regulations, standards, and guidelines, such as FDA regulations, ISO 13485, and MDR.
• Minimum of 10 years of experience in quality management in the medical device industry, with at least 5 years in a leadership role.
• Proven experience in implementing and managing quality systems and processes in a global organization.
• Experience in leading and managing global quality audits and inspections.
• Strong project management skills, with the ability to prioritize and manage multiple initiatives simultaneously.

Company Benefits:

• Competitive 401K program, health insurance, and HSA accounts
• Long term incentives in the terms of equity or stock at this level
• Relocation assistance provided for non-local candidates