Quality Engineer – Validation & Compliance (Med Devices)

Urgo Medical North America LLC; Fort Worth (TX); On-site; USD 105,000 - 110,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Company-paid and voluntary life Ins

Company-paid disability insurance and

EAP

401(k) with company match

Paid time off

Paid family leave

Job summary

Urgo Medical North America LLC is seeking a Quality Engineer to support development, validation, and compliant operations in a regulated medical-device environment. You will author protocols, execute qualification activities, and collaborate with Quality, Engineering, Manufacturing, Facilities, and Supply Chain.

The role requires a Bachelor's degree in a technical field and a minimum of three years in quality engineering or validation within regulated industries.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• At least 3 years in quality engineering/validation in a regulated industry.
• Experience authoring validation documentation (protocols, risk assessments, deviations).
• Experience with facility, utility, equipment qualification and validation is preferred.

Responsibilities

• Develop, review, and execute validation plans and final reports for facilities and equipment.
• Support IQ/OQ/PQ and process qualification activities.
• Define acceptance criteria, sampling, and test methods.
• Provide quality review of engineering documents and turnover packages.
• Lead quality risk-management activities per ISO 14971 where relevant.
• Investigate deviations, CAPAs, and change controls; perform root-cause analysis.
• Assist with supplier qualification and internal/external audits.
• Maintain complete quality records per data-integrity requirements.

Skills

Quality engineering

Validation

Regulatory compliance

Documentation

Risk management

Root-cause analysis

Project management

Data analysis

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Electronic quality management systems

Microsoft Office

Job description

Urgo Medical North America LLC is seeking a Quality Engineer to support development, validation, and compliant operations in a regulated medical-device environment. You will author protocols, execute qualification activities, and collaborate with Quality, Engineering, Manufacturing, Facilities, and Supply Chain.

The role requires a Bachelor's degree in a technical field and a minimum of three years in quality engineering or validation within regulated industries.