Our medical device client is seeking a Senior Director of Quality to oversee and shape its quality operations throughout the entire product lifecycle, including development, manufacturing, and post-market activities. This position will play a key role in maintaining regulatory compliance, advancing quality standards, and building a culture focused on continuous improvement. Success in this role requires extensive knowledge of quality systems, medical device regulations, and the ability to work effectively across teams.
Requirements of the Senior Director of Quality:
Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
10+ years of Quality Assurance experience in medical devices, including 5+ years in leadership roles.
Expert knowledge of FDA QSR, ISO 13485, EU MDR, and ISO 14971 risk management.
Proven track record guiding quality through development, scale-up, and product launch.
Strong background in CAPA, validation, DHFs, and quality engineering.
Exceptional leadership, communication, and cross-functional collaboration skills.
Ability to influence at all levels within an organization.
Proficient in Microsoft Office and quality management software.
Responsibilities of the Senior Director of Quality:
Lead and evolve the Quality Management System (QMS) in alignment with FDA, ISO 13485, and EU MDR standards.
Define and direct quality strategies across CAPA, nonconformance, audits, supplier quality, document control, risk, and change management.
Provide quality oversight for product development, validation, design transfer, and DHF completion.
Partner closely with R&D, Regulatory, Manufacturing, and Clinical teams to ensure quality across the full product lifecycle.
Oversee internal, supplier, and regulatory audits; drive timely resolution of findings.
Develop and report key quality metrics to leadership; use data to anticipate issues and guide proactive improvements.
Build and mentor a high-performing quality team, fostering growth and accountability.
Contribute to regulatory submissions and approvals through effective quality planning and documentation.
Manage quality initiatives and timelines to align with broader company objectives.
Take on additional projects and responsibilities as needed in a dynamic, growth-focused environment
