Director of Quality Assurance

Kandu Health, Inc.; California (MO); On-site; USD 125,000 - 150,000; Full time

Job summary

Ein innovatives Unternehmen im Gesundheitswesen sucht einen Director of Quality Assurance, um die Implementierung und das Management des Qualitätsmanagementsystems zu leiten. In dieser Schlüsselrolle werden Sie die Einführung eines neuen elektronischen QMS führen, die Integration von Qualitätssystemen nach Übernahmen koordinieren und sicherstellen, dass alle Qualitätsstandards eingehalten werden. Sie bringen umfangreiche Erfahrung in der Medizintechnik mit und sind in der Lage, komplexe Projekte erfolgreich zu managen. In einem dynamischen Umfeld werden Sie die Qualitätssicherung vorantreiben und zur Verbesserung der Lebensqualität von Patienten beitragen.

Benefits

Versicherung (Medizinisch/Zahnärztlich/Sichtbar)

401(k) mit Unternehmensbeitrag

Unbegrenzt PTO & Feiertage

Lebensversicherung, LTD und STD

Qualifications

• 5-10 Jahre Erfahrung in der Qualitätssicherung in der Medizintechnik.
• Erfahrung in der Implementierung von eQMS und ISO 13485.

Responsibilities

• Leitung der Implementierung eines neuen elektronischen Qualitätsmanagementsystems.
• Überwachung der Schulung der Mitarbeiter zu Qualitätsprozessen.

Skills

Qualitätsmanagement

Regulierungsanforderungen

Projektmanagement

Technische Schulung

Problemlösungsfähigkeiten

Kommunikationsfähigkeiten

Education

Bachelor in Ingenieurwesen

Tools

Elektronisches Qualitätsmanagementsystem (eQMS)

Job description

In 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 ($125,000 - $150,000)
• 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.