| Description | Regenesis is transforming digital health care with disruptive technology. Talented teams are working together to develop innovative therapy systems that change our customers' lives. We are looking for the best and the brightest to work together, grow, have a good time, and be a part of a company you can be proud of. Position Summary The Director of Quality is the senior quality leader responsible for developing, implementing, and sustaining the company-wide Quality Management System (QMS) in alignment with business objectives and regulatory requirements. This role serves as the organization's top-quality authority and management representative, owning audit readiness, compliance risk, and quality strategy across the enterprise. The Director of Quality sets and champions a proactive culture of quality and compliance, ensuring that patient safety, regulatory adherence, and continuous improvement are embedded into leadership decisions, operational strategy, and organizational behaviors. Essential Duties and Responsibilities The essential functions include, but are not limited to the following: Quality Strategy & Governance - Develop and execute the enterprise quality strategy in alignment with business goals, regulatory requirements (FDA QMSR, ISO 13485), and long-term organizational growth.
- Serve as the company's management representative for the Quality Management System.
- Make high-impact compliance, risk, and quality decisions affecting the entire organization.
- Proactively identify and mitigate compliance and quality risks across product lifecycle, operations, suppliers, and post-market activities.
Quality Management System (QMS) Ownership - Own and ensure the effectiveness, compliance, and continuous improvement of the company-wide QMS, including but not limited to; design controls and design transfer, manufacturing and production quality, CAPA, complaints, and nonconformances, Document control, training, and change management, Supplier quality and external partnerships, Validation, verification, and quality records
- Define, monitor, and optimize enterprise-level quality metrics and management review processes.
- Ensure sustained audit readiness and compliance for all internal, customer, and regulatory audits.
Leadership & Organizational Influence - Lead, develop, and manage the entire quality organization, including staffing, onboarding, coaching, performance management, and succession planning.
- Own and drive cross-functional quality initiatives across the organization.
- Advise executive leadership and key stakeholders on quality, compliance risk, and regulatory strategy.
- Set and champion a company-wide culture of quality by aligning leaders on expectations, modeling quality-first decision-making, and reinforcing sound compliance behaviors.
Regulatory & Audit Leadership - Lead all external regulatory inspections, third-party audits, and customer audits.
- Ensure effective responses to audit findings, regulatory observations, and compliance issues.
- Maintain strong working relationships with regulatory agencies and notified bodies, as applicable.
Continuous Improvement & Business Partnership - Drive continuous improvement initiatives focused on quality system maturity, operational excellence, and risk reduction.
- Partner with Operations, R&D, Supply Chain, Regulatory, and Commercial teams to ensure quality is integrated into business processes and decision-making.
- Ensure quality systems scale effectively with business growth and evolving regulatory expectations.
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