Software Quality Engineer II – Medical Device & Cloud QA

Planet Pharma; Lafayette (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Planet Pharma is seeking a Quality Engineering professional to support medical device software development and commercial software products. The role requires cross-functional collaboration with R&D and Quality to implement and maintain processes and procedural controls.

The position emphasizes design quality engineering per IEC 62304, QMS processes, and cloud-based software support, with a Bachelor’s degree and roughly two years of experience.

Qualifications

• Requires Bachelor's degree and practical knowledge of software quality practices.
• Minimum 2 years of relevant experience in software quality or verification.
• Experience with cross-functional teams in R&D and Quality.

Responsibilities

• Develops, modifies, applies, and maintains standards for software quality operating methods, processes, and procedures.
• Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
• Defines appropriate measures to ensure product quality and compliance with project requirements.
• Ensures that project documentation aligns with contractual and process requirements and is audit-ready.
• Reviews software system design, change specifications, and plans against requirements and testability objectives.

Skills

IEC 62304

QMS processes

Cloud software

Education

Bachelor's degree

Job description

Planet Pharma is seeking a Quality Engineering professional to support medical device software development and commercial software products. The role requires cross-functional collaboration with R&D and Quality to implement and maintain processes and procedural controls.

The position emphasizes design quality engineering per IEC 62304, QMS processes, and cloud-based software support, with a Bachelor’s degree and roughly two years of experience.