Quality Systems Engineer I (Hybrid)

Scorpion Therapeutics; Austin (TX); On-site; USD 70,000 - 110,000; Full time

Job summary

Scorpion Therapeutics seeks a Quality System Specialist to oversee the Quality Management System, ensure regulatory compliance, and support QMS activities across the organization. The role focuses on document control, change management, data analysis for KPIs, and regulatory readiness.

Key tasks include handling audits, CAPA and nonconformance processes, and driving continuous quality improvements. Strong analytical and communication skills are essential in this office-based position in Austin,

Qualifications

• Bachelor's degree in a scientific or technical field.
• 1+ year experience in quality assurance or engineering.
• ASQ certifications (CQA/CQE/LSS) preferred.
• Proficiency with electronic QMS and QA tools.
• Strong analytical, problem-solving, and communication skills.

Responsibilities

• Supporting internal and external audits.
• Managing CAPA and nonconformance processes.
• Driving continuous quality improvements.

Skills

Analytical thinking

Problem solving

Communication skills

Quality assurance experience

Education

Bachelor's degree in a scientific or technical field

ASQ certifications (CQA/CQE/LSS)

Tools

Electronic QMS tools

Job description

Role

Quality System Specialist responsible for overseeing and maintaining the company's Quality Management System (QMS) to ensure compliance with regulations and standards. Key tasks involve document control, change management, data analysis for KPIs, and supporting regulatory compliance activities.

Responsibilities

• supporting internal and external audits
• managing CAPA and nonconformance processes
• driving continuous quality improvements

Qualifications

• Bachelor's degree in a scientific or technical field
• 1+ year experience in quality assurance or engineering
• ASQ certifications (CQA/CQE/LSS) preferred
• proficiency with electronic QMS and QA tools
• strong analytical, problem-solving, and communication skills

High Value

• Focus on GxP compliance, ISO standards, and Good Manufacturing Practices
• experience with medical device manufacturing
• supporting audit readiness and CAPA effectiveness
• familiarity with quality documentation and regulatory standards

WorkSetup

Not specified, but implied to be an office-based role supporting company-wide quality activities.