Quality Engineer

Quality Engineer

At Urgo Medical, we believe innovation can transform lives. Our mission: to help patients heal faster and better, through cutting-edge products and innovative digital services. By joining us, you will discover our mission, our foundation, our commitment to local industrialization, and the authentic energy of our teams. If you want to combine passion, impact, and innovation, this position is for you!

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.

Duties and 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.

Competencies

• Strong knowledge of quality engineering, qualification, and validation principles in a regulated manufacturing environment.
• Working knowledge of FDA Quality System requirements, 21 CFR Part 11 as applicable, ISO 13485, good manufacturing practices, good documentation practices, and quality risk management.
• Ability to translate user, process, and compliance requirements into clear protocols, test cases, acceptance criteria, and defensible conclusions.
• Effective technical writing, protocol execution, data analysis, investigation, troubleshooting, and root-cause analysis skills.
• Strong organization and project-management skills, with the ability to manage multiple priorities and deadlines in a plant-startup environment.
• Sound judgment, attention to detail, and a consistent commitment to patient safety, product quality, compliance, and data integrity.
• Clear written and verbal communication and the ability to collaborate across Quality, Engineering, Manufacturing, Facilities, Supply Chain, and external suppliers.
• Ability to work independently, take ownership of deliverables, make risk-based recommendations, and escalate quality or compliance concerns appropriately.

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 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.
• 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.
• 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.

Benefits

• Health Insurance
• Dental Insurance
• Vision Insurance
• Company-paid and voluntary life Insurance
• Company-paid disability insurance and benefits
• EAP
• 401(k) with company match
• Paid time off
• Paid family leave

Salary Description

$105,000 - $110,000 annually, bonus eligible

EQUAL OPPORTUNITY EMPLOYER. It is our policy to abide by all federal, state and local laws prohibiting employment discrimination based solely on a person's race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, or any other protected status except where reasonable, bona fide occupational qualification exists. Urgo Medical North America participates in EVerify for all employees