The Director of Quality is a critical leadership role responsible for overseeing the comprehensive quality, compliance, and operational excellence of medical devices and drug products at the organization. This position will direct the integration of quality management systems, supplier quality, and quality engineering to support both device and drug segments, ensuring that products meet all customer and regulatory standards from concept through post-launch. The role requires a high level of expertise in regulatory compliance, quality system management, design controls, supplier management, and strategic leadership in a dynamic environment.
Responsibilities:
Serve as the primary point of contact for all quality-related activities, including but not limited to regulatory compliance, document control, CAPAs, complaints, NCMRs, deviations, risk management, supplier quality, design control, and internal and external audits.
Maintain and enhance a comprehensive quality management system (QMS) to ensure alignment with cGMP and other regulatory requirements across both clinical and commercial operations for FDA-regulated medical devices and drugs
Develop and implement quality systems and SOPs for device and drug quality management, ensuring alignment with cGMP and other regulatory standards.
Oversee all Quality Engineering functions, ensuring that devices and drugs are designed and manufactured in compliance with applicable FDA regulations (21 CFR Parts 820, 210/211) and ISO standards (ISO 13485, ISO 14971).
Lead supplier quality management for devices and drugs, managing the entire process from selection and onboarding to ongoing performance evaluations of contract manufacturers and other suppliers.
Direct design control activities, managing robust process validation, risk management, and ensuring compliance from concept through post-launch.
Act as a subject matter expert in design quality and risk management.
Coordinate cross-functional collaboration with Operations, Engineering, Drug Development, and R&D to integrate quality considerations throughout product development and manufacturing processes.
Lead and manages post-market surveillance, including device investigations for complaints and field actions
Lead the quality assurance team, responsible for hiring, mentoring, and overseeing staff development as the company expands.
Develop and manage quality metrics to monitor performance, inform management decisions, support continuous improvement initiatives, and prepare regulatory submissions for product approvals.
Qualifications:
Bachelor's degree in Engineering, Life Sciences, Chemistry, Chemical Engineering, or a related technical discipline; Master's degree preferred.
Minimum of 10 years of experience in quality roles within the medical device and/or pharmaceutical industry, with significant leadership experience including managing supplier quality and quality assurance teams across devices and drugs.
Comprehensive knowledge of FDA and international regulatory standards applicable to medical devices and pharmaceuticals, including 21 CFR Parts 820 and 210/211, ISO standards, and ICH guidelines.
Proven track record in managing quality systems, ideally in a startup environment, and leading comprehensive quality functions.
Strong leadership skills, with the ability to mentor and develop teams.
Excellent problem-solving, organizational, and communication skills.
Preferred Qualifications:
Certification as a CQE, CRE, Manager of Quality, and/or Six Sigma Black Belt.
Experience in Human Factors/Usability Engineering and reliability engineering.
Previous supervisory experience and a track record of effective team management.
Familiarity with Arena (electronic quality management system)
Familiarity with PMS for combination products including MDR
Travel Requirements:
Travel may be required for about 10% of the time to support key contract manufacturing operations.