Senior Quality Engineer - 251104

Senior Quality Engineer – Validation, Compliance & Quality SystemsMust be a U.S. citizen or hold a Green Card. C2C arrangements are not being considered at this time.First Shift: Monday - Friday, 7AM - 4PM6 Months Contract to HirePay Rate: $55 - $75 / HourPosition Overview:We are seeking a Senior Quality Engineer to lead validation, investigations, and quality system initiatives within a highly regulated, medical device reprocessing environment. This individual will play a critical role in ensuring product quality, regulatory compliance, and continuous improvement across product lifecycle activities—including development, manufacturing, and supplier management.This is a hands-on, high-impact role requiring strong ownership of validations, CAPA, and data-driven process improvements.Key ResponsibilitiesProcess Validation & Control (Must-Have)Lead and execute process validations including IQ, OQ, and PQDevelop and implement methods and procedures for process control, validation, testing, and inspectionEstablish risk-based validation strategies and define acceptance criteriaManage validation protocols, reports, deviations, and re-validation activitiesSupport and lead cleaning validation and contamination control processesCAPA, Investigations & Nonconformance ManagementLead investigations into nonconformances, deviations, and out-of-specification resultsPerform root cause analysis using tools such as 5 Whys, Fishbone, and statistical methodsDevelop, implement, and verify effectiveness of CAPA and SCARsAnalyze defective product trends and drive systemic corrective actionsData Analysis, SPC & Continuous ImprovementApply Statistical Process Control (SPC) to monitor and improve process performanceAnalyze process capability (Cp/Cpk), variation, and trends to guide decision-makingDesign and execute Design of Experiments (DOE) to identify sources of variationGenerate reports and use statistical quality methods to reduce defects and failure ratesRegulatory Compliance & Quality SystemsEnsure compliance with ISO 13485, 21 CFR Part 820, and other applicable regulationsMaintain audit-ready documentation and ensure traceability across processesSupport internal, external, and regulatory audits (FDA, ISO, customer)Drive improvements to the Quality Management System (QMS), including procedures and training updatesPerform quality reviews of design documentation, vendor records, and internal quality recordsProduct Development & Design QualityProvide Quality support in Product Development, Design Controls, and Risk Management activitiesContribute to CE Technical Files and regulatory documentationPartner with Regulatory teams on submissions (e.g., 510(k), letters to file)Build and maintain product documentation such as Device Master Records (DMR)Testing & Laboratory CoordinationDesign and perform experimental product testing and analysisCoordinate testing activities with internal and external laboratoriesEnsure testing supports product quality, validation, and regulatory requirementsSoftware & System Validation (Key Differentiator)Lead or support Computer System Validation (CSV) efforts for manufacturing and quality systemsValidate Manufacturing Execution Systems (MES) and other custom-built softwareApply risk-based validation approaches for systems impacting product qualityAddress gaps in software validation capabilities within the organizationSupplier QualityLead supplier qualification and ongoing performance managementManage supplier quality issues, including SCARs and corrective actionsCollaborate with suppliers to resolve nonconformances and drive improvementsLeadership & Cross-Functional SupportAct as a Quality lead in the absence of Quality ManagementTrain and coach team members on quality processes and best practicesPartner cross-functionally with Engineering, Manufacturing, and Regulatory teamsRequired QualificationsBachelor’s degree in Engineering or related technical field8–10+ years of experience in Quality Engineering within a regulated industryProven experience leading process validations (IQ/OQ/PQ)Strong experience with CAPA, nonconformances, and deviation investigationsProficiency in Quality Management Systems (QMS)Working knowledge of ISO 13485 and 21 CFR Part 820Preferred QualificationsExperience improving Quality Systems based on audit findings (procedures, training, compliance gaps)Strong background in software validation / Computer System Validation (CSV)Experience with Manufacturing Execution Systems (MES), especially custom-built systemsExperience with cleaning validation and contamination control processesBackground in medical device, pharmaceutical, or aerospace industriesExperience in validation management systems or quality system transformation initiatives