Hybrid Director of Quality

at Welldoc

• Job title: Director of Quality
• Job type: Full Time
• Experience level: Lead
• Salary: $150,000 - $190,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Cyber Security
• Location requirements: Hybrid, Columbia, United States

About the role

• Director of Quality at Welldoc leading Quality Assurance for Software as a Medical Device. Fostering a culture of quality across teams to support product development and compliance initiatives.

Responsibilities

• 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.
• Lead, mentor, and develop the Quality Assurance team, fostering a culture of high performance, continuous improvement, and deep regulatory expertise as the company grows.
• Direct the prioritization, delegation, and execution of all Quality Assurance operations, setting clear performance metrics and accountability standards across the function.
• 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.
• 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.
• 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.
• Driving continuous improvement initiatives using data from quality metrics, complaint trends, and corrective and preventive actions (CAPAs).
• Establish and lead comprehensive training programs for all relevant staff on critical processes, requirements, quality standards, and procedures.
• 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.
• 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.
• 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.
• Direct the management and execution of all third-party quality audits, including regulatory inspections.

Requirements

• 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.

Benefits

• generous PTO
• medical insurance
• dental insurance
• vision care
• life and disability insurance
• retirement benefits
• the opportunity to participate in health savings accounts and/or dependent care accounts.