Quality Assurance, Senior Manager

Position Title: Quality Assurance, Senior Manager

Department: Quality Assurance

Reports to: CSO

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar mapping system and integrated NanoAblate PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes.

Position Overview

The Quality Assurance, Senior Manager plays a key role in ensuring the traceable delivery of safe and effective cardiac 3D mapping and ablation products. Assumes ownership on continued efforts in gap assessments between China and US teams, DHF creation, IDE roadmap and executes on deliverables. Leads the development and maintenance of a compliant quality management system (e.g., ISO 13485, MDSAP, Regulation (EU) 2017/745) and partners with Regulatory Affairs team to implement global regulatory strategies aligned with company objectives.

Duties and Responsibilities

• Lead the development, implementation, and maintenance of a compliant Quality Management System (QMS) that meets international standards (e.g., ISO 13485, MDSAP, EU MDR).
• Serve as the owner of Quality System Compliance, ensuring internal processes, documentation, and records are audit-ready and support global submissions.
• Collaborate across departments (R&D, Operations, Clinical, and Regulatory Affairs) to ensure the QMS supports innovation while maintaining compliance and patient safety.
• Evaluate and evolve resources and infrastructure to sustain compliance as the organization grows and transitions from development to commercialization.
• Partner with the China team to identify and close gaps between NMPA and FDA quality and regulatory requirements, ensuring harmonization of design control and risk management practices.
• Support regulatory filings and facility/product approvals by providing critical quality system inputs and documentation for IDE, 510(k), PMA, and equivalent international submissions.
• Respond to and manage audits from global authorities and notified bodies (FDA, ANVISA, TGA, Health Canada, MHLW/PMDA, EU) to maintain certifications and approvals.
• Align quality procedures and regulatory strategies to enable business objectives, balancing innovation, compliance, and speed to market.
• Contribute to corporate strategic planning and objectives, ensuring quality priorities are embedded in company goals and product development plans.
• Serve as a trusted advisor to executive leadership, providing insight into quality risks, mitigation strategies, and opportunities for operational excellence.
• Translate strategy into action by applying logical, solution-oriented thinking and effective communication to influence decisions and align stakeholders.
• Lead a high-performing Quality team, fostering accountability, technical excellence, and collaboration across functions and geographies.
• Inspire and develop team members through mentorship, empowerment, and clear goal setting to promote professional growth and ownership.
• Create a culture of purpose, integrity, and continuous improvement that reflects EnChannel's values of professionalism, focus, and dedication.
• Lead effectively through change, cultivating adaptability and resilience within the team while ensuring clarity and alignment during organizational or regulatory transitions.

Education, Experience and Skills Required

• Bachelor's or higher.
• 10+ years of experience in quality assurance and regulatory affairs within the medical device industry, including 5+ years in leadership.
• Cardiac and/or Electrophysiology experience highly preferred
• Successful internal, external, and supplier audits and certifications.
• In-depth knowledge of international quality system and requirements.
• Strong communication skills with the ability to manage priorities under pressure.
• Effective in planning with the ability to utilize project management tools, resource management, and adapting to contingencies.
• Ability to travel internationally.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training.

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

Only qualified candidates will be contacted.