Quality Engineer

About the role

Use your skills where innovative technology solutions begin. ECLARO is looking for a Quality Engineer for our client in Plano, TX. ECLARO’s client is a leading technology solutions provider, collaborating with customers to manage their needs and achieve success in their business goals. If you’re up to the challenge, then take a chance at this rewarding opportunity! Position Overview: Quality Engineer with strong labeling and manufacturing experience to support quality, validation, and computerized system assurance activities within a regulated manufacturing environment. Hands-on experience with labeling systems and processes, CSA (Computer Software Assurance), validation testing, and quality documentation. Responsible for confirming that validation plans are appropriate, reviewing and validating testing results, and providing formal quality acceptance of validation activities.

Responsibilities

• Serve as the Quality Engineering subject-matter expert for product and manufacturing labeling systems and processes.
• Review, challenge, and confirm validation plans to ensure appropriate scope, risk assessment, testing strategy, and acceptance criteria.
• Evaluate and approve validation protocols, test scripts, requirements, traceability and validation reports.
• Review and validate testing results, ensuring requirements and acceptance criteria have been appropriately demonstrated.
• Provide formal Quality acceptance/approval of validation activities and results.
• Apply Computer Software Assurance (CSA) principles to computerized systems supporting labeling and manufacturing operations.
• Ensure labeling systems and associated processes meet applicable GxP, FDA, quality, and manufacturing requirements.
• Partner with Manufacturing, Quality, Validation, IT, Engineering, Regulatory and Operations teams on system implementations and changes.
• Review deviations, discrepancies, defects and validation exceptions and determine appropriate quality disposition.
• Ensure appropriate change control, risk management, CAPA and documentation practices are followed.
• Support validation of labeling software, printers, interfaces, databases and related manufacturing systems.
• Assess system changes and determine appropriate risk-based testing and validation requirements.
• Participate in audits and inspections by providing validation documentation, evidence and quality rationale.
• Identify opportunities to improve validation efficiency while maintaining compliance and product quality.
• Maintain strong documentation practices and ensure validation records are complete, accurate and inspection-ready.

Required Qualifications

• 5+ years of Quality Engineering, Validation, or Quality Systems experience in a regulated manufacturing environment.
• Strong labeling experience is mandatory - preferably supporting manufacturing, packaging, serialization or regulated product labeling.
• Direct experience with CSA / Computer Software Assurance.
• Hands-on experience reviewing and approving validation plans, protocols, test scripts and validation results.
• Experience providing Quality acceptance of validation deliverables.
• Strong understanding of risk-based validation and testing methodologies.
• Mandatory manufacturing experience within a regulated environment.
• Experience with GxP, FDA, GMP and/or regulated quality systems.
• Strong understanding of change control, deviations, CAPA and quality documentation.
• Ability to interpret requirements and determine whether testing adequately demonstrates intended use and compliance.
• Strong communication skills with the ability to challenge technical teams while maintaining a collaborative relationship.
• Labeling: Loftware, NiceLabel, BarTender, TEKLYNX
• Validation: CSA, CSV, IQ/OQ/PQ, risk-based testing, validation protocols
• Quality: CAPA, Change Control, Deviations, QMS
• Manufacturing: MES, ERP, SAP, serialization, barcode/UDI
• Compliance: FDA, GMP, GxP, 21 CFR Part 11, Annex 11
• Documentation: URS, FRS, RTM, test scripts, validation reports

Preferred Qualifications

• Experience with computerized systems validation (CSV) and transition to CSA methodologies.
• Experience with labeling platforms such as Loftware, NiceLabel, BarTender, Teklynx or similar.
• Experience with SAP, MES, ERP or manufacturing execution systems supporting labeling processes.
• Experience with serialization, barcode standards and automated printing systems.
• Experience supporting FDA inspections, internal audits or external regulatory audits.
• Experience developing or reviewing U