Quality Engineer

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

• 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
• Assign training requirements as specified in the QMS for on-boarding new employees

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.
• 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 documentation efforts related to regulatory submissions (e.g. 510(k))
• Tracks the pre-production and post-production documents for all product releases
• Ensure 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
• 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)
• Supports 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

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 to 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 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 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. The anticipated salary range for this role is $90,000-$125,000. Final determination of salary offer will be based on candidate experience. 

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.