Software Quality Engineer

Job Description

AppliedVR is looking for a mission-driven Software Quality Engineer with a passion for transforming healthcare through innovative technology to support our quality assurance and regulatory compliance efforts. Reporting to the Director of QA/RA and working closely with Product and Engineering stakeholders, the initial focus of the Quality Engineer will be providing critical quality oversight to ensure that our products are safe, effective, and compliant.

Roles & Responsibilities (are not limited to the following):

QMS Strategy: Establish and maintain software quality assurance processes, and controls to ensure compliance with FDA regulations, IEC 62304, and established standards.

Cross-Functional Leadership: Act as the Quality partner across Product, Engineering, and SQE teams to drive consistent understanding, adoption, and adherence to QMS requirements from pre-market development through post-market release.

Design and Development: Support the design and development lifecycle deliverables to ensure compliance to existing procedures, and maintaining the Design History File (DHF/DDF), Medical Device File (MDF), and traceability matrices per FDA 21 CFR 820.

Risk Management: Lead risk management lifecycle activities, including authoring and maintaining Risk Management files and Hazard Analyses in accordance with ISO 14971.

CAPA Leadership: own CAPA investigations from root cause to timely, effective resolution.

Continuous Improvement: Drive updates to procedures, work instructions, forms, and related systems to optimize business efficiency.

Systems & AI Innovation: Support the implementation and continuous improvement of eQMS tools, including AI-enabled solutions and Model Context Protocol (MCP), to automate routine workflows and enhance data accessibility while maintaining regulatory compliance.

Tool Administration: Manage the setup, maintenance, document routing, and approvals within the eQMS system to support team requests.

Audits & Inspections: Support internal and external audits, including FDA inspections and Notified Body audits, and assist in preparing comprehensive responses to observations.

V&V and Testing: Support verification, validation, and electrical safety/EMC testing (per IEC 60601) to ensure product and QMS compliance, as needed.

Post-Market Quality: Collaborate cross-functionally to investigate and resolve complaint-related software issues and drive corrective actions.

Experience & Qualifications Preferred

Bachelor’s Degree in Electrical Engineering, Computer Engineering, or related technical discipline

5+ years of software product development experience within the healthcare, medical device, or digital health/digital therapeutics space; working knowledge of Agile methodologies is preferred

Experience with medical device development under FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304 strongly preferred

Proven track record in risk management, CAPA ownership, and internal/external auditing processes

Proven ability to author Verification/Validation (V&V) plans and reports, with knowledge of medical device electrical safety/EMC compliance testing (IEC 60601) and non-product computer system validation (CSV)

Proficiency with Propel (or similar eQMS), JIRA, Confluence, and Google Workspace

Knowledge of AI-powered productivity workflow automation and familiarity with MCP, APIs, and data integration.

A quality mindset; strong attention to detail, with a solution-driven mindset and a high degree of accountability

Demonstrated ability to work cross-functionally and effectively communicate quality assurance requirements and expectations to non-quality stakeholders in a medical device work environment.

Excellent organizational and written/verbal communication skills

Ability to work autonomously, remotely, in a dynamic, fast-paced environment

Location

Anywhere in the US. This role requires approximately 10% travel or less for team meetings, audits, or site visits as needed.

Compensation

The salary range for this position is $120,000 to $130,000.  The salary range describes the minimum to maximum base salary range for this position across all US locations. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to relevant qualifications, depth of experience, skill set, certifications, training, education, and specific work location. The compensation packages may be adjusted based on candidate work location, due to differences in the cost of living for the given location.  Your recruiter can share more about the specific salary range during the hiring process.

Employee benefits include medical/dental/vision healthcare benefits, 401k retirement plan with a 4% employer match, employer-paid life insurance and long-term disability benefits, employee assistance program, remote work stipend and car allowance (for field reps only).

We offer the following paid time off programs:

Flexible Time Off for vacation

11+ paid holidays per year

Sick time is accrued at one hour for every 30 hours worked.

Accrual is capped at 72 hours.

Up to 12 weeks of paid parental leave for new parents

For more information on the position and benefits, please visit https://www.appliedvr.io/careers.