Quality Assurance Manager

Are you ready to elevate a groundbreaking medical device from prototype to global impact? AQMed is revolutionizing diagnostics, starting with CardiAQ™, a non-invasive device set to tackle the world's leading cause of death. Cardiovascular disease diagnostics are ripe for disruption, and CardiAQ™ is our answer—a device utilizing sophisticated magnetocardiography (MCG) enhanced by AI to offer faster, more accurate results than ever before. We need a Quality Assurance Manager to be the architect and guardian of quality, steering our innovative technology through rigorous design controls towards regulatory triumph and a successful product launch. This is a hybrid role for a strategic thinker and a meticulous doer, someone who can lead and contribute in equal measure to bring our vision to life.

• Provide quality leadership and guidance to the entire AQMed business unit.
• Forge strong partnerships across Product, Engineering, Test, Regulatory Affairs (RA), Clinical Affairs (CA), and with key contract manufacturers, ensuring quality considerations are seamlessly integrated into design inputs/output documents, risk documents, manufacturing procedures, and test plans & reports.

• Leverage your innovative mindset to co-create our quality and regulatory strategy, ensuring it’s as forward-thinking as our technology.
• Embody a spirit of continuous growth, eager to challenge conventional approaches and innovate beyond just maintaining systems.
• Experiment, propose bold ideas, and explore how AI tools can help the team work smarter, automate processes, and enhance compliance within our cutting-edge environment.

• Manage all quality-related vendor and partner activities, including interactions with suppliers, notified bodies, and regulatory agencies.
• Lead internal and external audits, overseeing preparation, participation, and the effective follow-up on corrective actions.
• Conduct technical reviews of supplier documentation, providing constructive and actionable feedback.

• Spearhead the full lifecycle of our electronic Quality Management System (eQMS) – from initial rollout and stakeholder integration to its meticulous day-to-day maintenance.
• Architect, implement, and maintain the Standard Operating Procedures (SOPs), work instructions, and controlled documentation within the eQMS, ensuring day-to-day compliance with ISO 13485 and FDA 21 CFR Part 820.
• Work with a contracted external software vendor to manage document control processes and training related to the eQMS

• Bachelor’s degree in Engineering (e.g. Mechanical, Electrical, Biomedical) or related technical field.
• 10+ years of experience in quality assurance and/or engineering with the medical device industry.
• 3-5 years of hands-on engineering experience in the medical device industry, with a strong understanding of design controls and product development processes.
• Proven experience with the implementation and management of electronic quality management systems.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant global medical device regulations.
• Excellent problem-solving and organizational skills with a strong attention to detail.
• Strong verbal communication and interpersonal skills, with the ability to influence and collaborate effectively.
• Hybrid, available for 3 days onsite in Palo Alto, CA.
• Ability to travel up to 15%. 

The US base salary range for this full-time position is expected to be $154k-$256k per year. Our salary ranges are determined by role and level. Within the range, individual pay is determined by factors including job-related skills, experience, and relevant education or training. This role may be eligible for annual discretionary bonuses and equity.