Medical Device Quality Manager (Software)

💡 Company

We give doctor’s superpowers.

Illuminant Surgical builds precision access and visualization technologies for all clinical procedures where accuracy matters, from spine surgery to cancer biopsy. Our breakthrough platform, Skylight™ is the world’s first real-time anatomical projection system that dispays images directly on the patient to give doctors an x-ray vision view for safer surgeries. Founded by two Stanford engineers and doctor, we’re a multidisciplary team of engineers, clinicians, regulatory, and business professionals united in using our skills to make an impact on patients. We’re backed by leading venture capital firms, the National Science Foundation, the National Institute on Aging, and the National Cancer Institute. Come help us solve tough problems at the intersection of software, hardware, and clinical practice in a beautiful office in sunny Culver City, CA next to the world’s leading hospitals and care centers. You’ll be joining a team where you will make a real difference. You’ll solve problems that have likely never been solved while working alongside talented, supportive teammates who challenge and inspire you. We push the limits of innovation, but we do it with humility, humor, and a shared commitment to each other’s success. We offer comprehensive healthcare benefits, 401(k), and generous equity packages. Learn more at illuminant.ai

💼 The Role

We are looking for a Quality Manager to drive key quality activities for our market-defining precision access and visualization platform. This role presents the unique opportunity to see a medical device through its product life cycle from design controls to pre-market submissions and post-market monitoring. They’ll have front-row seats in seeing their direct contributions impact clinical care. Longer term, they will support ongoing quality assurance and manufacturing. This individual will be responsible for managing the Quality System. This position shall ensure compliance with FDA design control requirements and other applicable requirements and standards during the product development life cycle to support regulatory approval submission, and transfer to manufacturing, and commercial release. Our ideal candidate is intrinsically motivated to create a culture of quality that ensures the safe and effective delivery of medical technology to patients everywhere. They will have deep experience in interpreting and putting into practice guidelines set by federal and international regulatory bodies. They will have a deep understanding of 21 CFR Part 820, and ISO 13485. They must have excellent written and oral communication abilities to lead training and motivate cross-disciplinary groups to abide by quality principles. They are energized by the accelerated growth, deep autonomy, and trajectory-setting impact that comes with joining as an early employee. To excel in this role, you will have worked in quality roles at medical device companies in its design and manufacturing phases.

📝 Responsibilities

• Support the development of safe and effective products, including Software in Medical Devices (SiMD), by applying design assurance principles, facilitating/verifying compliance to design control requirements, and implementing risk management throughout the development life cycle.
• Review, prepare, and/or execute test protocols and reports and validations.
• Create and/or revise quality system procedures to ensure compliance or drive improvement.
• Oversee all aspects of quality assurance, document control, and quality control to ensure compliance with FDA QSR requirements, and plan for transition to QMSR.
• Conduct new employee quality system training and required training on new/revised quality system procedures and quality policy, and provide guidance/training on applicable standards.
• Keep abreast of applicable regulations and standards, perform and/or coordinate gap assessment of new quality system regulations/standards
• Establish, validate, and manage the electronic document control system, including the control of external documents.
• Interface with contract manufacturers and suppliers to analyze data and provide solutions for quality issues.
• Manage and/or conduct internal and external audits.
• Regularly exercises independent judgment and discretion regarding matters of significance.
• Prepares quality compliance status reports, trend findings, and escalates critical issues that warrant further actions.
• May supervise one or more individuals.
• Perform special projects and other duties as assigned.

🏆 Qualifications

Required

• Must reside in Los Angeles Metropolitan Area or be willing to relocate. This is an in-person role. There is no remote option.
• Bachelor’s degree in life sciences and/or engineering
• At least five years of medical device quality experience
• Thorough knowledge of FDA QSR, ISO 13485, ISO 14971, and ISO 62366-1
• Prior work experience with Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD)
• Experience supporting 510(k) and/or De Novo regulatory submissions

Bonus

• Completed IEC 62304 Audit.
• Training in, or working knowledge of, Six Sigma or Lean principles
• ASQ or RAC Certification

1. Resume + Materials Review - We'll get you a decision to move to a phone screen or to pass for now within 2 days. A resume, and compilation of previous works would be very helpful for us to decide if a fit is good.

2. Initial Phone Screen - We'll get to know each other. We'll ask general questions on your background, and we'll share more about what we're doing and what you'll be working on.

3. Technical Interview (1-2 Rounds) - Generally open discussions on technical topics you'll be working on.

4. Culture Interview - Meet the whole team and talk about how and why you do your work.

5. Reference Calls (1-2 References) + Background Checks