Quality Engineer I (On-Site - Austin, TX)

Scorpion Therapeutics; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Scorpion Therapeutics is hiring a Quality Engineer I to support new product development and the existing product line manufacturing within a medical device company focused on cardiac and vascular devices.

Responsibilities include technical quality support, analyzing non-conformances, and executing validations for equipment, processes, and software. You will work with R&D and manufacturing to ensure product safety, effectiveness, and FDA compliance.

Qualifications

• Bachelor’s degree in engineering or equivalent.
• 0–2 years’ experience, preferably in FDA-regulated biomedical or medical device industry.
• Knowledge of GMP, Quality System Regulations, and ISO standards.

Responsibilities

• Provide technical quality support for products and processes.
• Analyze non-conformances and participate in investigations.
• Execute and analyze validations for equipment, processes, and software.
• Assist in development and documentation of qualifications/validations to ensure product safety, effectiveness, and compliance.
• Collaborate with R&D and manufacturing to support product launches.
• Engage in risk management including FMEAs.
• Review test methods and test data.
• Investigate non-conformances and customer complaints.

Education

Bachelor’s degree in engineering or equivalent

Job description

Role

Quality Engineer I supporting new product development and existing product line manufacturing within a medical device company specializing in cardiac and vascular devices.

Responsibilities

• provide technical quality support
• analyze non-conformances
• execute and analyze validations for equipment, processes, and software
• assist in development and documentation of qualifications/validations to ensure product safety, effectiveness, and compliance.
• Collaborate with R&D and manufacturing to support product launches
• risk management including FMEAs
• review test methods
• investigate non-conformances and customer complaints.

Requirements

• Bachelor’s degree in engineering or equivalent
• 0-2 years’ experience, preferably in FDA-regulated biomedical or medical device industry
• knowledge of GMP, Quality System Regulations, and ISO standards.

Additional Information

HighValue: medical devices, cardiac/vascular, new product development, validations, risk management, FDA compliance, Quality Engineering. WorkSetup: not specified, likely on-site or hybrid.