Director of Quality

Company & Culture

Welldoc is at the forefront of digital health, driven by a powerful mission: empowering better cardiometabolic health through AI-powered, personalized digital tech, with a vision to be the leading advanced AI digital technology partner across the healthcare industry. We're a team passionate about leveraging cutting-edge science to improve lives, united by core values of collaborative innovation, accountability to excellence, customer focus, efficiency, and unwavering integrity, quality, and safety.

At Welldoc, you'll thrive in a collaborative and innovative environment where your contributions directly impact our mission. Recognized as a Great Place to Work for the past four years and named to Modern Healthcare's Best Places to Work 2025, as well as being an industry thought leader featured at SXSW and in the Wall Street Journal and Economist, we invite you to make a real difference in healthcare with us.

Job Purpose

The Director of Quality will be a key member of a growing team developing and manufacturing Software as a Medical Device (SaMD). The position will manage pre-market, post-market Quality Assurance (QA) activities and provide leadership in fostering a culture of quality at all company sites.

• Establish a Vision and Strategy : Define, champion, and execute the overarching strategic vision for the Quality Assurance function, ensuring it scales effectively to support the company's expanding product pipeline, development activities, and market objectives.

• Organizational Leadership and Development: Lead, mentor, and develop the Quality Assurance team, fostering a culture of high performance, continuous improvement, and deep regulatory expertise as the company grows.

• Governance and Operational Excellence: Direct the prioritization, delegation, and execution of all Quality Assurance operations, setting clear performance metrics and accountability standards across the function.

• Drive Data-Driven Quality: Design, implement, and oversee a statistically and analytically driven Quality Program that proactively measures, monitors, and ensures the attainment of the highest quality standards across the organization.

• Product Development Process Ownership: Responsible for defining, implementing, and ensuring the consistent quality of a Welldoc's product development processes and overseeing the entire product lifecycle to meet business and customer expectations through a quality-focused approach. Responsible for training the organization on product development processes to ensure consistency and quality.

• Quality Management System (QMS) Ownership: Own, strategically enhance, and administer the company's Quality Management System (QMS), ensuring its continued compliance, efficacy, and suitability for the current business scale and future strategic needs.

• Continuous Improvement: Driving continuous improvement initiatives using data from quality metrics, complaint trends, and corrective and preventive actions (CAPAs).

• Organizational Education and Expertise : Establish and lead comprehensive training programs for all relevant staff on critical processes, requirements, quality standards, and procedures. Serve as the primary subject matter expert on all quality initiatives for both internal executive reporting and external stakeholders.

• Strategic Risk Management: Maintain a robust awareness of internal and external market/regulatory conditions, providing executive management with timely updates, strategic risk assessments, and data-backed solutions to address any issues impacting product quality, compliance, or the company's reputation.

• Management Representative Role: Act as the Management Representative for the company's ISO13485-certified environment, responsible for reporting on the performance of the QMS and any need for improvement to executive leadership.

• Cross-Functional Integration and Alignment: Collaborate strategically with Product, Regulatory, Clinical, and other departments to architect and implement integrated, company-wide systems and processes that ensure end-to-end product quality and continuous regulatory compliance.

• Strategic Input: Participate as a key contributor in operational, financial, and strategic discussions that have a material impact on the entire organization, ensuring quality objectives are factored into all corporate decisions.

• Audit and Partner Management: Direct the management and execution of all third-party quality audits, including regulatory inspections. Oversee all quality assurance activities with strategic external partners and suppliers, ensuring their alignment with the company's QMS and quality expectations.

Required Skills & Experience

• 10+ years' experience in medical device Quality Assurance, specifically with both Class I and Class II devices.
• Experience with medical devices containing software or Software as a Medical Device required.
• Must have 5+ years' experience in managing and leading QA teams
• Experience in key QMS areas including design controls, complaint handling, CAPA, supplier controls, internal audits, risk management and post-market surveillance.
• Experience implementing and maintaining of QMS as per ISO 13485 and applicable regulations of MDSAP (US, Canada, Australia, Japan) and European Union under MDR / CE marking.
• Experience or practical knowledge of ISO 14971, IEC 62304, IEC 62366 and cybersecurity standards.
• Excellent verbal and written communications skills. Must be able to communicate effectively at all levels of interaction.
• Experience with various software development / lifecycle models including Agile.
• Demonstrated ability to translate regulations or regulatory guidance into internal policies, procedures, and work instructions.
• Comfortable working in a fast-paced and agile environment.
  Proven ability to translate strategic vision into measurable outcomes and successful execution.

WellDoc operates in ISO 13485 and MDSAP regulated and HITRUST compliant environments. Therefore, it is expected that all employees will have either prior experience working in those environments or, will be trained to understand the requirements needed to work and support those requirements and culture as they relate to individual roles and responsibilities.

Required Education

BS degree in Mathematics, Business, Computer Science, Engineering or equivalent

Compensation & Benefits

Welldoc offers a competitive compensation package which, in addition to salary, includes generous PTO, medical insurance, dental insurance, vision care, life and disability insurance, retirement benefits. and the opportunity to participate in health savings accounts and/or dependent care accounts. The anticipated salary range for this role is $150,000 - $190,000 per year. Exceptional candidates may exceed the budgeted range.

Upon receipt of a conditional offer of employment, you may be required to complete and clear a multi-panel drug screening process. This screening is in connection with requirements set by certain of the Company's customers, with which you may be working in this role, and will at all times be administered all applicable laws.

Welldoc is an equal opportunity employer and prohibit discrimination and harassment of any kind. We offer an inclusive workplace and will not tolerate discrimination against any job candidate or employee due to age, race, religion, color, ethnicity, national origin, gender, gender identity/expression, sexual orientation, membership in an employee organization, medical condition, family history, genetic information, veteran status, marital status or parental status .