Senior Digital Quality Lead — Regulated Health Software

Scorpion Therapeutics

Chicago (IL)

On-site

USD 120,000 - 160,000

Full time

2 days ago

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Job summary

Scorpion Therapeutics seeks a Lead Digital Quality specialist to provide quality oversight for software, cloud solutions, and digital platforms in biopharma. This role focuses on regulated non-medical-device software used in healthcare and digital health, guiding quality practices across the product lifecycle.

You will collaborate with Product, Engineering, Regulatory, Cybersecurity, and Data teams to develop quality procedures, automate processes, and ensure compliance with evolving ISO, IEC,

Qualifications

Bachelor's degree in Engineering, CS, Life Sciences or 10+ years relevant experience.
6+ years in software quality, engineering, or regulatory compliance.
Experience with Agile, DevSecOps, and software lifecycle principles.

Responsibilities

Guide quality practices across product lifecycle: requirements, design, verification, validation, release, change management.
Review documentation.
Support risk management, cybersecurity, and compliance.
Develop procedures and automate processes.
Train cross-functional teams.
Monitor quality metrics.
Support audits and investigations.
Ensure adherence to evolving standards like ISO 13485, IEC 62304, and FDA software guidance.

Skills

Agile methodologies

DevSecOps

Technical writing

Problem solving

Quality mindset

Cross-functional collaboration

Education

Bachelor's degree in Engineering/CS/Life Sciences

Job description

You will collaborate with Product, Engineering, Regulatory, Cybersecurity, and Data teams to develop quality procedures, automate processes, and ensure compliance with evolving ISO, IEC,

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