Software Quality Engineer

Base Pay Range

$90,000.00/yr - $/yr

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.

• 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.
• Supports Quality Assurance activities related to product development and new product introduction activities.
• Supports Quality Management System (QMS) activities including processing of controlled documents, CAPA, complaints, supplier evaluations, and training.
• Process documentation requirements in support of Welldoc’s product development process.
• Updates and maintains training and configuration of controlled documents.
• Assigns training requirements as specified in the QMS for on-boarding new employees.

• 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.
• Supports the activities of document approval, distribution, modification, retention and schedules in accordance with internal policies and regulatory requirements.
• Supports the management and documentation of other QMS activities including audits, CAPA, training, etc.
• Contributes to and participate in the implementation of change control processes for product and QMS.
• Supports the documentation efforts related to regulatory submissions (e.g. 510(k)).
• Tracks the pre-production and post-production documents for all product releases.
• Ensures good documentation practices (GDP) compliance with respect to QMS and production related records and documentation.
• Supports 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.
• Conduct required periodic review/inspection assessments of QMS documentation (e.g. executed design, development, production and distribution forms for compliance to US 21
  
  CFR
  11, US 21
  
  CFR
  820, and other requirements as applicable).
• Supports training personnel on document / change control processes and annually assists Quality Management in the preparation for, conduct of, and follow-up activities associated with site visits from regulatory or other accrediting agencies.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc. in accordance with IEC 62304 and 21 CFR 820.
• 3+ years’ experience with FDA and ISO regulated product development and ISO quality systems, including Design Controls, Production and Process Controls, CAPA and…