Company & Culture

Welldoc®, a digital health leader revolutionizing cardiometabolic care, is integrating personalized, real-time and actionable insights into the daily lives of individuals living with cardiometabolic conditions, enabling improved health and outcomes. Welldoc’s comprehensive digital health platform provides AI-powered digital coaching across pre-diabetes, diabetes, hypertension, heart failure and weight and obesity management, with integrated mental wellbeing and sleep support. Welldoc’s flagship product, BlueStar®, is an FDA-cleared digital health solution that guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team. These capabilities are now integrated into the Welldoc platform, providing comprehensive and flexible support across conditions. Welldoc partners with health plans, health systems and employers with the goal of extending care, improving health and reducing costs. The company has achieved 11 510(k) clearances for diabetes functionality within its digital health platform, and an IP portfolio of 43 patents for its advanced AI and first-in-class tech. With over 75 clinical publications, Welldoc has also built an extensive library of clinical research, including many publications focused on the value of combining CGM with AI-powered digital health solutions. Welldoc is a thought leader in the evolving world of AI powered digital health and has been showcased in prestigious conferences and publications, including South by Southwest, Wall Street Journal and the Economist.

Welldoc has been named the “Best Overall Digital Health Company” by MedTech Breakthrough. The company recently received the 2024 Innovation Award and was a finalist for the AI Excellence Award from Business Intelligence Group.

For more information, visit https://welldoc.com/. Follow us on LinkedIn and Twitter.

At Welldoc, we are focused on transforming healthcare by creating an environment that fosters collaboration, learning, and innovation. We value the personalities and experiences of every one of our team members, giving everyone the opportunity to thrive as we make our mission a reality.

*Welldoc® Diabetes and Welldoc Diabetes Rx is an FDA-cleared medical device, intended for use by healthcare providers and their adult patients with type 1 or type 2 diabetes. For full labeling information, visit www.welldoc.com. The other Welldoc App products are non-FDA-cleared and intended to promote general wellness and education/self-management of various chronic disease states.

Job Purpose

• A key member of the QA organization of a growing medical device company developing and manufacturing software as medical devices.
• The position is located in Columbia, Maryland and will interface with the R&D engineering team located in Bangalore, India.
• Champion Quality Assurance activities related to product development, new product introduction and provide leadership in fostering a culture of quality
• Provide inputs to software R&D designs, develop test strategies for software systems, improve quality processes as they apply to software systems
• Proactively provides guidance to the functional teams to ensure Quality System compliance
• Partner with Product Development to review requirements to ensure appropriate level of rigor to software validation and verification as well as address risk management, quality planning, design input, design output, design verification/validation, and design transfer
• Partner with the Software QA and Development team in order to execute software test and quality assurance including software verification strategies, test scripts, and traceability to requirements
• Provide quality support for the change control process including quality approval of design changes/enhancements, bug fixes, and infrastructure changes.
• Actively identifies, drives, and participates in project efforts related to compliance
• Oversees the scheduling and auditing of the Quality System controls, including external vendor assessments
• Evaluates regulatory landscapes both nationally and internationally to contribute to business strategy

Responsibilities

• Contribute to and participate in the implementation of document and change control processes and systems for compliance to applicable medical device regulatory and quality management system (QMS) requirements
• Support the management of all QMS (e.g. policies, procedures, etc.), production (e.g. batch records) and Regulatory Affairs (e.g. 510(k) compilation and submission to FDA) related documentation and records
• Serve as the QMS documentation SME, providing guidance to colleagues regarding the requirements, adequacy and compliance status of documentation and records related to QMS, production and Regulatory Affairs
• Reviewing for and ensuring good documentation practices (GDP) compliance with respect to QMS and production related records and documentation. This includes providing guidance to a document originator regarding how to remediate or correct documents prior to their finalization and retention in the document management system or file
• Supporting or co-managing the document and change control process to include working directly with authors, reviewers, and approvers to facilitate document and change order workflow; assisting with document formatting; ensuring proper document organization; ensuring required metadata and other applicable data inputs for compliance are provided; and tracking and trending of open tasks to facilitate timely turn-around
• Conducting required periodic review/inspection assessments of QMS documentation (e.g. executed design, development, production and distribution forms for compliance to US 21CFR11, US 21CFR820, and other requirements as applicable)
• Maintain complaint records, and support regulatory reporting of device incidents
• Assist with non-conformity and corrective and preventive action (CAPA) processes per US 21CFR820
• Manage document control for marketing, customer care and other departments within WellDoc as applicable
• Co-authoring documents and change control related procedures and training presentations
• Training personnel on document / change control processes and annually assisting Quality Management in the preparation for, conduct of, and follow-up activities associated with site visits from regulatory or other accrediting agencies

Required Skills & Experience

• Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc. in accordance to IEC 62304 and 21 CFR 820
• 10+ years’ experience with FDA and ISO regulated product development and ISO quality systems, including Design Controls, Production and Process Controls, CAPA and complaints
• Experience with MDSAP, ISO 13485, ISO 14971, FDA QSR (21 CFR Part 11, 21 CFR 820), Health Canada, TGA and EU MDR
• High attention to detail and meticulous record-keeping
• Ability to work both independently and as part of a highly integrated team
• Highly proficient in multitasking and project management and organization skills
• Excellent communication and problem-solving skills
• Comfortable working in a fast-paced and agile environment

Preferred Experience:

• Prior experience utilizing and/or administering an electronic document management system.
• Prior experience auditing or reviewing Design Control and production records.
• Prior experience supporting and/or participating in compliance audits or inspections.
• Prior experience with JIRA, Confluence, Asana, Basecamp, Smartsheet, Zoho, or related software.
• Experience with software validation and software hazards analysis preferred.
• Experience with software quality and software as a Medical Device (SaMD) a plus
• Experience with diabetes devices a plus

Welldoc operates in ISO 13485 and MDSAP regulated and HITRUST and SOC 2 Type II 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, Computer Science or 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. While the anticipated salary range for this position is between 120-175K/year with the expectation that most candidates will fall around the midpoint of the range, exceptional candidates may exceed the 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 under all applicable laws.

Welldoc is an equal opportunity employer and prohibits 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.