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Quality Assurance Manager

Quality Assurance Manager

SandboxAQPalo Alto, CA, US
30+ days ago
Job type
  • Full-time
Job description

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 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.

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 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.

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

  • 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.

    SandboxAQ welcomes all.

    We are committed to creating an inclusive culture where we have zero tolerance for discrimination. We invest in our employees' personal and professional growth. Once you work with us, you can't go back to normalcy because great breakthroughs come from great teams and we are the best in AI and quantum technology.

    We offer competitive salaries, stock options depending on employment type, generous learning opportunities, medical / dental / vision, family planning / fertility, PTO (summer and winter breaks), financial wellness resources, 401(k) plans, and more.

    Equal Employment Opportunity : All qualified applicants will receive consideration regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.

    Accommodations : We provide reasonable accommodations for individuals with disabilities in job application procedures for open roles. If you need such an accommodation, please let a member of our Recruiting team know.

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    Quality Assurance Manager • Palo Alto, CA, US

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