Quality Engineer: Validation & Compliance (Medical Devices)

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

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

EAP

401(k) with company match

Paid time off

Paid family leave

Job summary

Urgo Medical North America is seeking a Quality Engineer to advance validation activities across facilities, equipment, and processes. The role partners with Quality, Engineering, Manufacturing, and Supply Chain to ensure systems are fit for use and compliant with regulatory standards.

You will author and execute validation documents, support IQ/OQ/PQ activities, lead risk assessments, and drive CAPA investigations.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline; equivalent relevant education and experience may be considered.
• Minimum three years of quality engineering, validation, manufacturing engineering, or related experience in a regulated industry.
• Experience authoring, reviewing, and executing validation or qualification documentation (protocols, risk assessments, deviations, traceability, reports).
• Experience with facility, utility, equipment, process, cleaning, or computerized-system qualification and validation is strongly preferred.
• Experience supporting deviations, nonconformances, CAPAs, change controls, root-cause investigations, and effectiveness checks is required.

Responsibilities

• Develop, review, approve, and execute validation plans, protocols, test scripts, risk assessments, traceability matrices, and final reports for facilities, utilities, equipment, processes, cleaning, and computerized systems.
• Support commissioning and qualification activities (IQ, OQ, PQ, CPQ) using risk-based approach.
• Define acceptance criteria, sampling requirements, test methods, and evidence to demonstrate conformance.
• Document protocol execution, identify deviations, assess impact, and ensure resolution before validation approval.
• Provide Quality review and approval of engineering documents, specs, drawings, and turnover packages.
• Support quality risk-management activities, including FMEA and risk controls per procedures and ISO 14971.
• Initiate investigations of deviations, nonconformances, CAPAs, and change controls; perform root-cause analysis and verify corrective actions.
• Assess changes for validation, regulatory, documentation, training, and product quality impact and ensure revalidation if needed.
• Support process development, transfer, scale-up, and readiness by identifying quality requirements and controls.
• Review manufacturing and quality data, identify trends, and drive continuous improvement without compromising quality.
• Develop and revise quality procedures, work instructions, forms, specs, and validation templates; train on approved docs and good documentation practices.
• Support supplier qualification and supplier-quality activities, including review of technical documentation and validation deliverables.
• Participate in internal and regulatory audits; prepare records and assist with responses and corrective actions.
• Maintain complete, accurate, attributable, legible, contemporaneous records per data-integrity requirements.

Skills

Quality engineering

Validation

Regulatory compliance

Documentation

Root-cause analysis

Education

Bachelor's degree in Engineering/Life Sciences

Job description

Urgo Medical North America is seeking a Quality Engineer to advance validation activities across facilities, equipment, and processes. The role partners with Quality, Engineering, Manufacturing, and Supply Chain to ensure systems are fit for use and compliant with regulatory standards.

You will author and execute validation documents, support IQ/OQ/PQ activities, lead risk assessments, and drive CAPA investigations.