QA Manager

About Us:

We are a cutting-edge medical device start-up dedicated to restoring upper extremity function for stroke patients. Having recently qualified our new manufacturing facility and with production scaling up, we are also integrating a recently acquired company into our operations. We are seeking a highly motivated and experienced Quality Assurance Manager to own the implementation and tactical execution of our quality management system and drive key strategic projects.

Position Overview:

The QA Manager 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.

Key Responsibilities:

• 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.

Qualifications:

• 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.

Why Join Us:

• Opportunity to play a pivotal role in a growing medical device start-up focused on making a meaningful impact on patients' lives.
• Collaborative, innovative, and mission-driven work environment.
• Significant opportunity for professional growth and leadership development.
• Be part of a team that values quality, compliance, and continuous improvement.
• Compensation: The expected salary range for this role is $125,000 to $150,000 per year, commensurate with experience and qualifications.

Location: Van Nuys, CA (This is a full-time, onsite position requiring regular presence at our facility.)

Additional Requirements:

• Due to the critical need for close interaction with our Operations and Engineering teams and the leadership responsibilities of this position, the Quality Assurance Manager will be required to maintain a consistent onsite presence at our facility in Van Nuys, CA.

Please note that the salary information is a general guideline only. Neurolutions considers factors such as the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, and internal equity, as well as location, market, and business considerations when extending an offer.