Quality Engineer

Urgo Medical North America LLC•Fort Worth, TX

30d•$105,000 - $110,000

About The Position

The Quality Engineer supports the development, execution, and maintenance of quality and validation activities for the URGO Medical. This role authors and executes quality protocols; supports facility, utility, equipment, process, cleaning, and computerized-system qualification and validation; and provides quality engineering oversight for plant startup and routine operations. The Quality Engineer partners with Quality, Engineering, Manufacturing, Facilities, Supply Chain, and other functions to ensure that systems and processes are fit for intended use, risks are appropriately controlled, and applicable regulatory and company requirements are met.

Requirements

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 the medical-device, pharmaceutical, biotechnology, or another regulated industry.
Demonstrated experience authoring, reviewing, and executing validation or qualification documentation, including protocols, risk assessments, deviations, traceability documents, and final reports.
Experience supporting deviations, nonconformances, CAPAs, change controls, root-cause investigations, and effectiveness checks is required.
Ability to read and interpret engineering drawings, technical specifications, process diagrams, protocols, test data, and applicable regulatory requirements.
Must be legally authorized to work in the United States without restriction, consistent with applicable law and company policy.

Nice To Haves

Experience with facility, utility, equipment, process, cleaning, or computerized-system qualification and validation is strongly preferred.
Knowledge of medical-device manufacturing processes, aseptic or controlled manufacturing environments, water or utility systems, automated equipment, and validation lifecycle practices is preferred.
Proficiency with Microsoft Office applications and experience with electronic quality, document, maintenance, or validation management systems is preferred.

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, as assigned.
Support commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and process performance qualification activities using a documented, risk-based approach.
Define acceptance criteria, sampling requirements, test methods, and objective evidence needed to demonstrate that systems and processes meet approved specifications and intended use.
Document protocol execution accurately and contemporaneously; identify deviations or discrepancies, assess their impact, and ensure satisfactory resolution before validation approval or release for use.
Provide Quality review and approval of engineering documents, specifications, drawings, commissioning records, calibration documentation, preventive-maintenance requirements, and turnover packages.
Support or lead quality risk-management activities, including risk assessments, failure mode and effects analyses, and identification of appropriate controls in accordance with applicable procedures and ISO 14971 principles, where relevant.
Initiate, investigate, and support deviations, nonconformances, CAPAs, and change controls; perform root-cause analysis and verify that corrective and preventive actions are effective.
Assess proposed changes for validation, regulatory, documentation, training, and product-quality impact and ensure required qualification or revalidation activities are completed before implementation.
Support process development, transfer, scale-up, and operational-readiness activities by identifying quality requirements and ensuring appropriate controls are established and documented.
Review manufacturing and quality data, identify trends, recommend improvements, and support continuous-improvement initiatives without compromising product quality or compliance.
Develop and revise quality procedures, work instructions, forms, specifications, and validation templates; provide training on approved documents and good documentation practices.
Support supplier qualification and supplier-quality activities, including review of technical documentation, quality issues, changes, and validation deliverables, as applicable.
Participate in internal audits, customer audits, and regulatory inspections; prepare supporting records and assist with responses and corrective actions.
Maintain complete, accurate, attributable, legible, contemporaneous, original, and enduring quality records in accordance with data-integrity and document-control requirements.
Perform other quality engineering duties and support plant-startup and operational activities as assigned.