Senior Quality Engineer

Title: Quality Engineer IV – Medical DevicesLocation: St. Petersburg, FL (Onsite) 9+ month contractIndustry: Medical Devices / Healthcare TechnologyRate: TBDPosition OverviewWe are seeking an experienced Quality Engineer IV to provide quality leadership across medical device product development, design assurance, and lifecycle management activities.This position will serve as the Quality representative on cross-functional engineering teams, ensuring compliance with FDA regulations, ISO 13485, ISO 14971, and applicable medical device quality standards.The ideal candidate will have hands-on experience with medical device design controls, risk management, verification, and validation (V&V), design transfer, and regulatory compliance, along with strong technical and cross-functional leadership skills.Key ResponsibilitiesDesign Quality & Regulatory ComplianceLead quality activities throughout medical device product development, design changes, and lifecycle management.Ensure compliance with FDA 21 CFR Part 820 (QMSR), ISO 13485, ISO 14971, and applicable regulatory requirements.Review and approve design inputs, outputs, design reviews, risk management documentation, and design control deliverables.Maintain requirements traceability across product specifications, risk controls, and verification and validation activities.Ensure electronic quality and design records comply with 21 CFR Part 11 requirements.Verification, Validation & Risk ManagementDevelop, review, and approve verification and validation plans, protocols, reports, and test methods.Apply statistical techniques to sampling plans, acceptance criteria, capability studies, and engineering data analysis.Evaluate testing methodologies, equipment, and laboratory results to ensure accuracy, reliability, and compliance.Support product risk assessments and implementation of risk mitigation strategies.Design Transfer & Quality SystemsSupport design transfer activities, manufacturing readiness, process validation, and production quality requirements.Collaborate with Engineering, Manufacturing, Supplier Quality, Regulatory Affairs, and external laboratories.Lead or support root cause investigations, nonconformance resolution, corrective and preventive actions (CAPA), and continuous improvement initiatives.Support supplier qualification, component changes, and product quality investigations.Participate in regulatory audits, technical documentation reviews, and quality system assessments.Technical LeadershipProvide technical guidance to engineering and product development teams on design assurance and quality requirements.Identify and communicate product quality, patient safety, and regulatory compliance risks.Collaborate with internal teams, customers, suppliers, and regulatory stakeholders.Drive improvements in quality processes, documentation, and engineering practices.Required QualificationsBachelor's degree in Biomedical, Mechanical, Electrical, Systems, Software, Quality Engineering, or a related technical discipline.5+ years of experience in medical device quality engineering, design assurance, or product development quality.Strong hands-on experience with medical device design controls and design history documentation.Demonstrated knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 (QMSR).Working knowledge of 21 CFR Part 11, including electronic records, electronic signatures, and data integrity.Experience reviewing design inputs and outputs, requirements traceability, risk management files, and V&V documentation.Experience with design transfer, product changes, CAPA, nonconformance investigations, and quality management systems.Knowledge of statistical analysis, root cause analysis, and structured problem-solving techniques.Strong technical documentation, communication, and cross-functional collaboration skills.Ability to independently manage quality deliverables across multiple engineering projects.Preferred QualificationsExperience with Class II or Class III medical devices.Background in electromechanical, software-enabled, sterile, implantable, diagnostic, or combination-product technologies.Familiarity with IEC 62304, IEC 62366-1, IEC 60601, ISO 11607, or ISO 10993 standards.Experience with Minitab, electronic Quality Management Systems (eQMS), or Product Lifecycle Management (PLM) platforms.Certifications such as ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), ISO 13485 Lead Auditor, or Six Sigma.