Quality Engineer Software

Overview

Quality Engineer Software responsible for software quality plans, design validation and oversight across the software life cycle for medical software, including post-market performance and combining Agile with medical software development.

What you'll do

• Ensure appropriate SW Quality plans are made that include all stages of the software life cycle and support SW Quality Plan design.
• Validate key design inputs such as usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
• Provide effective oversight of the execution of the SW Quality Plan, any Risk Management activities, and all design related activities during the software lifecycle.
• Lead quality related problem solving for software.
• Use post-market analytics and statistics to report on software performance in the field and provide feedback to manufacturing, suppliers or design teams.
• Initiate field actions when required.
• Act as single point of contact on the project team to ensure software design quality related requirements/criteria are completed and meet SW Quality standards for every PRP milestone.
• Make a substantial contribution to ways of combining Agile with medical software development.

What you'll need

• Working knowledge of appropriate global medical device regulations, requirements and standards.
• Working knowledge of consumer product regulations and industry standards, such as 21 CFR Parts 803, 806 and 820.
• 5-7 years of work experience in a related field.
• Experience in IEC 62304 and software quality.

Nice to have

• AI/ML skills.

Details

• Hybrid work model: an average of at least 3 days working from the office and up to 2 days from home for full-time employees.