Director Of Quality - Medical Device

Director of Quality - Medical Device

Location: Remote - US

Role Overview:

As the Director of Quality, you will play a pivotal role in ensuring that our medical devices meet the highest standards of quality, safety, and regulatory compliance. You will lead a team of quality professionals, oversee quality management systems, and collaborate with cross-functional teams to drive continuous improvement throughout the product lifecycle. This role offers a unique opportunity to make a significant impact on patient care and the success of our company.

Responsibilities:

• Lead a team of quality professionals, including hiring, training, and performance management, to create a culture of excellence and collaboration.
• Lead and manage internal and external quality audits, ensuring compliance with regulatory standards and driving corrective and preventive actions as needed.
• Provide strategic leadership and vision for the quality department, setting clear goals and objectives that align with the company's overall mission and values.
• Establish and monitor key quality performance indicators (KPIs), utilizing data-driven insights to identify trends, areas for improvement, and opportunities for innovation.
• Develop and implement quality management systems, policies, and procedures that comply with relevant regulatory requirements (FDA, ISO, etc.) and industry best practices.
• Champion a culture of continuous improvement by promoting Lean Six Sigma principles, root cause analysis, and proactive problem-solving techniques.
• Drive the development and execution of comprehensive quality plans, including risk assessment, validation strategies, and post-market surveillance.
• Stay up-to-date with industry trends, regulatory changes, and emerging technologies to drive innovation and maintain the company's competitive edge.
• Collaborate closely with Research and Development, Regulatory Affairs, Manufacturing, and other departments to ensure seamless integration of quality processes throughout the product development lifecycle.
• Engage with regulatory authorities as a point of contact for quality-related matters, ensuring effective communication and collaboration.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field; Master's degree preferred.
• Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or other relevant certifications are a plus.
• Demonstrated ability to drive change, make data-driven decisions, and promote a culture of continuous improvement.
• A minimum of 8 years of experience in quality management within the medical device industry, including leadership roles.
• Experience with Lean Six Sigma methodologies and tools for process improvement is highly desirable.
• Excellent communication skills, with the ability to collaborate effectively with cross-functional teams and communicate complex quality concepts to diverse audiences.
• Proven track record of leading successful quality teams and managing complex projects in a remote or virtual work environment.
• Strong understanding of FDA regulations (21 CFR Part 820) and ISO quality standards (ISO 13485) is essential.
• Strong problem-solving skills, including root cause analysis and risk assessment.