Director of Quality Assurance

Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Kandu n April 2025, Kandu Health and Neurolutions merged to form Kandu Inc. to pioneer an integrated approach to stroke recovery, combining FDA-cleared brain-computer interface technology with personalized telehealth services. The company’s IpsiHand device is durable medical equipment that enables chronic stroke survivors to regain upper extremity function in daily home use. Combining this advanced technology with the support of expert clinicians offers a comprehensive path to recovery– helping survivors improve mobility, independence, and quality of life. Kandu extends recovery beyond the hospital through principal illness navigation, providing one-on-one education, care coordination, and advocacy; grounded in clinical evidence and informed by the lived experiences of patients and their families. Now, the companies are merging to pursue the same goal. As part of the merger, Kandu completed the first close of a $30 million financing. To read the full announcement click here. The Director of Quality Assurance will be a critical leader within our organization, responsible for the practical implementation and ongoing management of our quality management system (QMS). This role will involve leading key projects such as the rollout of a new electronic QMS, the integration of an acquired company's quality system, and the training of critical suppliers on medical device regulations. The ideal candidate will possess a strong engineering background in medical devices, hands-on quality experience, and proven leadership abilities to drive compliance, foster collaboration, and ensure the highest standards of quality and regulatory adherence. This role reports directly to the Chief Operating Officer. What You’ll Do Electronic Quality Management System (eQMS) Rollout Lead the implementation of our validated electronic QMS, ensuring a smooth transition for all stakeholders. Oversee the update and creation of work instructions and other controlled documents within the eQMS. Develop and deliver comprehensive training materials and programs for employees on the new eQMS. Identify and rectify administrative document errors (e.g., incorrect numbers, versions) to ensure data integrity. Acquired Company Quality System Integration Develop and maintain a detailed project plan for the integration of the acquired company's quality management system. Conduct meetings with stakeholders from both organizations to assess the current state of their quality processes and identify integration needs. Lead the revision and harmonization of quality documents and procedures to achieve a unified and compliant QMS. Key Supplier Training and Development Serve as the primary point of contact for quality-related matters with a key global electronics manufacturing supplier. Develop and deliver tailored training programs on the practical application of FDA design control requirements (21 CFR Part 820) for the supplier's development teams. Manage the project to ensure the supplier's processes align with our quality and regulatory expectations. Conduct technical reviews of supplier documentation and provide constructive feedback. Quality Management System (QMS) Ownership and Maintenance Take ownership of the day-to-day implementation and maintenance of the company's QMS, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820. Manage document control processes, including revision, approval, and distribution of controlled documents within the eQMS. Oversee the training program within the eQMS, ensuring employees are appropriately trained on relevant procedures and regulations. Support internal and external audits, including preparation, participation, and follow-up on corrective actions. Leadership and Team Collaboration Provide leadership and guidance to the QARA Project Manager. Collaborate effectively with cross-functional teams, including Manufacturing, Engineering, and Product Development, to ensure quality considerations are integrated into all aspects of the business. Contribute to the development of the overall quality and regulatory strategy in collaboration with leadership. Complaint Handling and Corrective Actions Oversee the complaint handling process, ensuring timely and thorough investigations and effective corrective actions. Participate in material review board (MRB) activities as needed. Monitor the effectiveness of corrective and preventive actions (CAPA) and drive continuous improvement initiatives. What You’ll Bring Bachelor’s degree in Engineering (e.g., Mechanical, Electrical, Biomedical) or a related technical field. Minimum of 5-10 years of progressive experience in quality assurance and/or engineering within the medical device industry. Minimum of 3-5 years of hands-on engineering experience in the medical device industry, with a strong understanding of design controls and product development processes. Minimum of 3-5 years of experience in a leadership role, demonstrating ownership, accountability, and effective communication. Proven experience with the implementation and management of electronic quality management systems (eQMS). Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant global medical device regulations. Demonstrated success in managing complex projects, including cross-functional teams and external stakeholders. Experience in developing and delivering technical training programs. Excellent problem-solving, analytical, and organizational skills with a strong attention to detail. Strong communication (written and verbal) and interpersonal skills, with the ability to influence and collaborate effectively. Preferred Qualifications Experience with integrating quality systems from acquired companies. Experience training suppliers on medical device regulations. Certification in quality (e.g., CQE, CQA) or regulatory affairs (e.g., RAC). Experience with electromechanical medical devices. What We Offer Competitive Compensation Insurance (Medical/Dental/Vision) 401(k) with company Unlimited PTO & Holidays Life Insurance, LTD and STD Please note that the salary information is a general guidance only. Kandu Health, Inc. considers factors such as scope and responsibilities of the position, candidate’s work experience, education/training, key skills and internal parity, as well as location, market and business considerations when extending an offer. Kandu Health is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance and Manufacturing Industries Hospitals and Health Care and Manufacturing Referrals increase your chances of interviewing at Kandu by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Director of Quality Assurance” roles. Senior/Executive Director, Head of Quality Westlake Village, CA $210,000.00-$280,000.00 1 week ago Sr. Director, Food Safety & Quality Assurance Newport Beach, CA $225,000.00-$275,000.00 1 day ago Irvine, CA $250,000.00-$330,000.00 4 days ago Irvine, CA $178,022.00-$254,317.00 1 week ago Santa Ana, CA $150,000.00-$160,000.00 2 days ago Los Angeles, CA $150,000.00-$180, hours ago Head of Quality - Design (Director Level) Thousand Oaks, CA $153,600.00-$241,340.00 3 days ago Director, Quality Initiatives (Director III) Orange, CA $192,386.00-$307,817.00 3 weeks ago Head of Quality - Design (Director Level) Associate Director, Quality Assurance, Change Controls Director of Quality and Mission Assurance Simi Valley, CA $148,891.00-$211,365.00 1 week ago Senior Manager, Quality Assurance (M-F Day Shift) Director of Quality and Certification (H/F) - SAFRAN AEROSYSTEMS OXYGEN US Quality Manager RN - Full Time, Day Shift Victorville, CA $56.18-$81.68 7 months ago Head of Hardware Product Quality – Spectacles Executive Director Quality - PSJMC - Burbank Director of Quality and Regulatory Affairs Executive Director Quality - PSJMC - Burbank Sr. Food Safety & Quality Assurance Manager Vernon, CA $110,000.00-$135,000.00 1 week ago Thousand Oaks, CA $153,600.00-$241,340.00 Just now Engineering Director - Supplier Quality | Diabetes Santa Clarita, CA $190,000.00-$205, hours ago Director of Quality Assurance - Cell and Gene Therapy Operations We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr