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# Software Quality Engineer

- **Company:** ENTEGEE, Inc.
- **Location:** Denver, CO, United States
- **Experience:** Experienced
- **Salary:** $93,600.0 - $114,400.0
- **Contract:** Temporary contract
- **Skills:** Agile Methodology, Software as a Service, Cloud Computing, Software Quality, Software Engineering, Verification and Validation (Software), System Testing, Software Verification
- **Published:** September 16, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=eb9a9328fa945a23

## About the Role

The ideal candidate will have experience supporting software quality and validation activities throughout the product lifecycle, with a strong understanding of medical device regulations, design controls, and software verification and validation., * Bachelor's Degree in a STEM discipline

 * 2+ years of Quality Engineering, Design Quality, Software Quality, or Validation experience
 * Experience with Computer System Validation (CSV) or Software Validation
 * Knowledge of medical device software development processes
 * Experience with Quality Management Systems (QMS)
 * Understanding of software verification and validation methodologies
 * Experience supporting regulated product development environments
 * Familiarity with change control processes for medical device products
 * Strong communication and cross-functional collaboration skills

Preferred Qualifications

 * Experience with:
 * IEC 62304
 * ISO 13485
 * EU MDR
 * Medical device industry experience
 * Cloud-based software support experience
 * Agile development experience
 * Knowledge of design control requirements
 * Regulatory and compliance experience
 * Experience with quality testing and validation tools

Desired Skills

 * Design Quality Engineering
 * Software V&V
 * Computer System Validation
 * Quality Systems
 * Regulatory Compliance
 * Product Development
 * Risk Management
 * Change Control
 * Cloud Technologies
 * Agile Methodologies

## Description

We are seeking a Quality Engineer II to support medical device software development and commercially available software products in a regulated healthcare environment. This role will work closely with Quality, R&D, and cross-functional teams to ensure compliance with software development processes, validation requirements, and regulatory standards., * Support software quality activities for medical device and cloud-based software products

 * Partner with R&D and Quality teams to implement and maintain quality processes and procedures
 * Participate in software verification and validation (V&V) activities
 * Support design quality engineering efforts throughout product development
 * Ensure compliance with IEC 62304, ISO 13485, EU MDR, and internal quality management systems
 * Assist with change control activities for medical device software products
 * Review and maintain software development documentation and quality records
 * Support risk management, testing, validation, and regulatory compliance initiatives
 * Contribute to continuous improvement of quality systems and development processes
 * Participate in Agile development activities and cross-functional project meetings