Director of Quality

4 weeks ago

Denver, United States TalentBridge Holdings Corporation Full time

Talentbridge

is partnered with a leading innovator in the medical device industry, committed to improving patient outcomes through cutting-edge technology and rigorous quality standards. We are seeking a highly skilled and experienced Director of Quality to lead our Quality Assurance team in Denver, Colorado and ensure compliance with global regulatory standards.

Job Summary:

The Director of Quality will be responsible for overseeing and managing all aspects of our quality systems, ensuring compliance with ISO 13485, MDD, CMDR, and other relevant standards. This role involves the implementation and maintenance of quality management systems, risk management, and the development and optimization of processes. The ideal candidate will have extensive experience in the medical device industry, with a proven track record in quality system management and global regulatory compliance.

Key Responsibilities

Develop, implement, and maintain quality management systems in compliance with ISO 13485 and other relevant standards. Ensure compliance with global regulatory requirements, including MDD, CMDR, FDA, and other applicable standards. Lead the development and optimization of quality assurance processes to enhance efficiency and effectiveness. Implement and manage risk management processes to identify, evaluate, and mitigate risks associated with product quality and safety. Drive continuous improvement initiatives to enhance product quality, reduce defects, and streamline operations. Provide strategic oversight and guidance for quality assurance activities across multiple locations Oversee internal and external audits, ensuring timely and effective resolution of any findings. Lead, mentor, and develop the quality assurance team, fostering a culture of quality and compliance. Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure alignment on quality objectives. Establish and monitor key performance indicators (KPIs) to track and report on quality performance.

Qualifications:

Bachelor’s degree in engineering, Life Sciences, or a related field; Master’s degree preferred. Minimum of 10 years of experience in quality assurance within the medical device industry. In-depth knowledge of ISO 13485, MDD, CMDR, and other relevant regulatory standards. Proven experience in quality system implementation and management. Strong understanding of risk management principles and practices. Demonstrated ability to develop and optimize quality processes. Experience with global regulatory compliance and managing quality assurance across multiple locations. Excellent leadership, communication, and interpersonal skills. Strong analytical and problem-solving abilities. Certification in quality management (e.g., ASQ CQE, CQA) is a plus.

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