Overview
Associate QA Engineer Jobs in Alpharetta, GA at Priority Technology Holdings, LLC
Company & Culture
** Please note, this remote role is open to candidates in the mid-Atlantic region and who are open to monthly travel to Columbia, MD. Candidates who are located near the Company HQ will be expected to follow a 2 day/week hybrid schedule.
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.
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
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
5+ 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 $120,000-$175K,000/year with the expectation that most candidates will fall around the midpoint of the range. Exceptional candidates may exceed the range if education and experience warrant.
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 .
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Title: Associate QA Engineer
Company: Priority Technology Holdings, LLC
Location: Alpharetta, GA
