Software Quality Engineer

Welldoc

Columbia (MD)

On-site

USD 90,000 - 125,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

Job summary

A digital health company is seeking a Software Quality Engineer to work in Columbia, MD. The role involves supporting Quality Assurance activities for developing software as medical devices, ensuring compliance with FDA and ISO standards. Candidates should have 3+ years of experience in regulated environments and a BS degree in a relevant field. This full-time position offers a competitive salary with benefits including medical insurance and 401(k).

Qualifications

3+ years’ experience with FDA and ISO regulated product development.
Experience with ISO 13485, ISO 14971, FDA QSR.
Comfortable working in a fast-paced and agile environment.

Responsibilities

Support Quality Assurance activities for product development.
Contribute to document and change control processes.
Ensure compliance with regulatory requirements.

Skills

Experience with SDLC processes

FDA regulated product development

Attention to detail

Project management skills

Excellent communication

Education

BS Degree in Mathematics, Computer Science or Engineering

Tools

JIRA

Confluence

Asana

Job description

Base Pay Range

$90,000.00/yr - $125,000.00/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.

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.
Assigns 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 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 21CFR11, US 21CFR820, 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.

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 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 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.

Required Education

BS Degree in Mathematics, Computer Science or Engineering or equivalent.

Benefits

Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
Disability insurance

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.

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 in accordance with all applicable laws.

Seniority Level