Quality Assurance Manager
Quality Assurance Manager
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Job Description
About SandboxAQ
SandboxAQ is a high-growth company delivering AI solutions that address some of the worlds greatest challenges. The companys Large Quantitative Models (LQMs) power advances in life sciences financial services navigation cybersecurity and other sectors.
We are a global team that is tech-focused and includes experts in AI chemistry cybersecurity physics mathematics medicine engineering and other specialties. The company emerged from Alphabet Inc. as an independent growth capital-backed company in 2022 funded by leading investors and supported by a braintrust of industry leaders.
At SandboxAQ weve cultivated an environment that encourages creativity collaboration and impact. By investing deeply in our people were building a thriving global workforce poised to tackle the worlds epic challenges. Join us to advance your career in pursuit of an inspiring mission in a community of like-minded people who value entrepreneurialism ownership and transformative impact.
About the Role:
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 worlds leading cause of death. Cardiovascular disease diagnostics are ripe for disruption and CardiAQ is our answera 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.
What Youll Do:
Leadership and Innovation
- 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 its 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.
Serve as a Key External Quality Ambassador
- 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.
Lead and Uphold Our eQMS for Regulatory Success
- 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
About You:
- Bachelors 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.
SandboxAQ welcomes all.
Required Experience:
Manager
Employment Type
Full-Time
