Senior Quality Manager

Location: San Francisco Bay Area, CA

Full Time

Role Overview

As Senior Quality Manager, you will own Sanmai’s Quality Management System and culture of compliance. Reporting to the Chief Medical Officer, you will be responsible for ensuring that Sanmai’s medical devices meet the highest standards of safety, efficacy, and regulatory compliance throughout their lifecycle. You will serve as the internal leader for quality governance, risk management, and continuous improvement, while also being a trusted partner to regulators, external auditors, and suppliers.

This role is a blend of strategic leadership and hands-on execution. You will shape quality strategy, build scalable systems, and embed quality-first thinking across engineering, clinical, operations, and product teams.

What You Will Achieve

As the Senior Quality Manager, your work will establish and maintain a culture of quality that ensures Sanmai’s devices are trusted, compliant, and impactful. Your contributions will:

  • Guarantee that Sanmai’s products meet the highest standards of safety and efficacy.

  • Ensure regulatory and audit readiness across all stages of development and commercialization.

  • Embed a culture of compliance and continuous improvement across teams.

  • Enable speed-to-market by creating scalable, efficient quality processes.

  • Ensure Sanmai’s reputation as a company committed to ethical, safe, and transformative technology.

Your leadership in quality will ensure that Sanmai’s innovations not only reach patients and providers but do so with excellence and integrity.

Responsibilities

Quality System Ownership

  • Own the design, implementation, and continuous improvement of Sanmai’s Quality Management System (QMS) in alignment with FDA, ISO 13485, and international standards.

  • Ensure quality requirements are embedded from early R&D through design transfer, commercialization, and post-market surveillance.

  • Author and deploy SOPs, work instructions, and templates across design controls, risk management, supplier management, CAPA, complaint handling, and more.

Regulatory & Compliance Alignment

  • Serve as a key partner to Regulatory Affairs in preparing submissions and ensuring audit readiness and key partner to clinical team to ensure clinical trial activities meet GCP and device regulations.

  • Oversee document control, training records, and data integrity related to clinical studies.

  • Act as a liaison with external regulatory bodies, auditors, and consultants.

Risk & Safety Leadership

  • Establish and maintain frameworks for risk management, non-conformance handling, and corrective/preventive actions (CAPA).

  • Lead efforts to proactively identify, assess, and mitigate product quality and safety risks.

  • Lead internal audits, prepare for FDA inspections, and manage external audits (suppliers, ISO, notified bodies).

  • Ensure design history files (DHF) and device master records (DMR) are inspection ready.

Cross-Functional Enablement

  • Partner with Engineering, Clinical, Operations, and Product teams to ensure quality processes support innovation and speed without compromising compliance and to integrate quality thinking into day-to-day workflows.

  • Provide guidance and coaching across the company on quality standards, documentation, and audit practices.

Qualifications

 Experience

  • 10+ years of industry experience in medical devices and technology development.

  • 5+ years in quality management roles, with direct responsibility for FDA/ISO 13485-compliant QMS.

  • Deep knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and GCP.

  • Experience standing up quality systems from scratch or scaling them rapidly.

  • Experience in Class II and/or Class III medical device.

  • Successful execution of supplier audits, regulatory inspections, and quality certifications.

  • Experience managing and developing quality teams.

  • Bachelor’s degree required; Master’s degree or relevant certification (CQA, Six Sigma, RAC) preferred.

Skills

  • Strong communicator with executive presence and ability to influence across levels.

  • Expertise in FDA/ISO 13485 quality systems for hardware and software devices.

  • Proficiency in developing scalable quality frameworks, audit preparation, and compliance strategies.

  • Ability to lead risk management, CAPA processes, and post-market surveillance.

  • Demonstrated competence working across engineering, clinical, operations, and regulatory teams.

Attributes

  • High degree of autonomy, accountability, and reliability.

  • Organized and efficient with a bias for action.

  • Collaborative leader who fosters a culture of quality and continuous improvement.