Sr. Director, Quality Assurance

Job Summary: We are seeking a strategic and passionate Sr. Director, Quality Assurance leader to lead all Quality Assurance (QA) activities with emphasis on global compliance with US and global medical device authorities. This individual will represent Presidio Medical in a positive and professional manner in all interactions with the executive leadership team, customers, consultants, regulatory, quality, clinical staff and all government regulatory agencies. Essential Duties and Responsibilities: Develops, implements, and manages Quality Management System to ensure that products meet required specifications for quality, function, and reliability prior to delivery. Ensure that our 3rd party relationships are in line with our QMS and actively engage with internal R&D, Supply Chain and Operations to support day-to-day needs Serve as the Company's senior representative with the FDA and regulatory authority inspectors to ensure compliance with FDA and global QMS requirements. Drive continuous improvement initiatives and ensure that quality is embedded in all processes and technology. The ability to partner across the business to ensure new product development and manufacturing processes meet customer expectations by executing on a clear quality strategy aligned to the company's business strategy & objectives. Align and drive support for early-stage pipeline projects and products. Participate in the review of new product and technology recommendations, with specific responsibility for assessing quality risk factors throughout the product development lifecycle. Represent company interests with national government agencies, industry associations, and/or other organizations in all regions for the purpose of collaboration on policy changes, standard setting and ensuring compliance with legislation, regulations and/or guidelines that impact the business. Recruit, hire, train, and lead and develop a high-performing QA team. Consistently partner with the executive team and make presentations to the Board of Directors as needed. Comply with Presidio Medical's quality system requirements as well as any applicable regulatory requirements. Comply with all health and safety regulations, policies, and work practices. Other duties as assigned. Qualification Requirements: 12+ years of experience culminating in Quality Assurance and Compliance working with Class III, active implantable devices or 15+ years of relevant Quality experience. Demonstrated success in quality assurance efforts including the ability to strategically work with/negotiate with FDA and global inspectors. Possess management leadership experience as a Senior Director of Quality and Compliance, with a strong cross-disciplinary understanding of an entire business entity, including Research & Development, Clinical, Marketing, Operations, Manufacturing, and Regulatory. Excellent project planning, project management, negotiation and presentation skills. Have successfully partnered with R&D to support the development of current and future products. Have a successful track record of hiring and developing high quality individuals in a startup environment. Direct all administrative activities associated with the department, including establishing departmental goals and objectives; prepare and maintain operating, expense and capital budgets; issue relevant operating procedures; and recruit, train and assess key department personnel. Ensure compliance education, training and adherence. Knowledge/skills/Abilities: Knowledgeable of FDA (21CFR 820), ISO 13485, EU MDR and ISO14971 Possessing demonstrable leadership skills can move others to action, including peers, superiors and subordinates. Have a personality that is adaptable and a good fit with an entrepreneurial, high growth company. Be responsive and "quick-on-the-feet" when experiencing changes in company objectives and/or market conditions. Have a "hands-on" management style and entrepreneurial work ethic and commitment. Able to develop others, and manage performance of team through coaching and feedback, willing/able to share personal knowledge and experience with others, Subject matter expertise in Quality and Compliance activities. Experience in Quality Systems maintenance The ability to work independently Excellent verbal and written communication skills Excellent problem-solving skills Excellent interpersonal skills and a spirit of teamwork Education: BS/BA in an Engineering, Scientific or similar fields Salary Range: $240,000.00 - $275,000.00 The final salary offered will be determined based on the candidate's professional experience, qualifications, and geographic location. Note: This role is not sponsorship eligible. This role is based in San Mateo, CA

Created: 2026-03-10