Software Quality Engineer

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

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

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance