Senior Quality Engineer

BEPC is actively looking for Senior Quality Engineer, in Irving, TX area!W2 Contract – 6 months with possible extensions!Benefits include medical, dental, vision, and life insurancePay Rate: $39.00 - $42.00/hour - Determined based on experience (Paid Weekly)Work Model: Onsite roleNote : This is a W2 only role — C2C, C2H will not be consideredSummary of the RoleBEPC is seeking a highly motivated Sr. Quality Engineer to join our client's site in Irving, TX. This role will support quality operations by providing routine quality assurance support for manufacturing and operational areas. The position evaluates manufacturing quality performance, develops criteria to monitor and improve existing processes, identifies and eliminates compliance risks, and supports quality assurance systems and manufacturing processes. The role also leads nonconformance investigations, supports validation activities, and applies quality engineering principles to drive continuous improvement and regulatory compliance.Summary of Duties and ResponsibilitiesProvide leadership within the Quality Operations department to ensure quality objectives and goals are achieved.Help develop and drive the strategic direction of quality operations and compliance initiatives.Conduct failure investigations and collaborate with business partners to implement robust corrective solutions that prevent recurring quality issues.Review pending investigation reports requiring Quality Assurance approval.Coach and train employees responsible for generating investigations.Escalate extraordinary investigation situations to Quality Assurance management for final approval.Support the facility in identifying and eliminating compliance risks.Ensure appropriate specifications and procedures related to products are utilized.Ensure adherence to compliance requirements and policies related to:External manufacturersPackaging and labelingProduct testingReturned goodsProduct complaintsProduct recallsSupport, consult, train, and lead quality improvement projects focused on reducing defects, minimizing waste, and increasing reliability.Utilize Quality Engineering tools and techniques to:Develop quality plansConduct and participate in FMEA activitiesSupport reliability engineering activitiesConduct process and system auditsAnalyze routine and test data to identify improvement opportunities.Provide statistical support for:Sampling plan analysisDesign of Experiments (DOE)Pareto analysisANOVAStatistical Process Control (SPC)Other statistical applications as requiredServe as technical reviewer for validation protocols and reports.Investigate nonconforming material and determine root cause, corrective actions, and disposition recommendations for the Material Review Board.Apply research and benchmarking activities to develop innovative quality solutions and support implementation.Develop and report progress on personal performance objectives aligned with facility quality goals.Prioritize work to meet established deadlines.Serve as the Quality Operations subject matter expert for assigned responsibility areas.Guide and coach Quality Operations Technicians in managing nonconforming product through the nonconforming system.Demonstrate independent application of:Data Integrity (DI)Good Manufacturing Practices (GMP)Good Documentation Practices (GDP)Communicate business-related issues and opportunities to the next level of management.Follow all Health, Safety, and Environmental practices.Ensure compliance with all federal, state, local, and company regulations, policies, and procedures.Perform other assigned duties as needed.Main QualificationsEducation : Bachelor's degree required. Strong preference for Engineering or a related technical field.Experience : Minimum of 4 years of related quality and manufacturing experience. Experience in an FDA-regulated environment. Experience in the medical device, pharmaceutical, or other highly regulated industry.Required Knowledge, Skills & AbilitiesKnowledge of ISO 13485 and/or cGMP regulations.Demonstrated project management and project leadership skills.Technical training and experience with:StatisticsLean ManufacturingSix Sigma methodologiesMeasurement System Analysis (MSA)Statistical Process Control (SPC)Design of Experiments (DOE)Reliability methodsHands‑on troubleshooting and problem‑solving skills.Strong technical understanding of manufacturing equipment and processes.Knowledge of:Quality System Regulation (21 CFR Part 820)ISO 13485 requirementsMedical Device Directive (MDD)Canadian Regulations.Preferred qualificationsASQ Certification such as:Certified Quality Engineer (CQE)Certified Quality Manager (CQM)Certified Reliability Engineer (CRE)Certified Quality Auditor (CQA)Process Excellence certification.#J-18808-Ljbffr