Senior Quality Engineer

Senior Quality Engineer, Medical Devices Position Summary We are seeking a Senior Quality Engineer to support quality initiatives across product development, manufacturing, and post-market activities within a regulated medical device environment. This role partners cross-functionally with Engineering, Operations, Regulatory Affairs, and Supply Chain teams to ensure compliance with applicable quality system requirements while driving continuous improvement efforts. Key Responsibilities Provide quality engineering support for medical device manufacturing and product development activities.Lead and support investigations related to nonconformances, customer complaints, deviations, and CAPAs.Participate in risk management activities, including development and maintenance of risk assessments and FMEAs.Support process validation, equipment qualification, and test method validation activities.Analyze quality metrics and process data to identify trends and improvement opportunities.Review and approve quality system documentation, including procedures, protocols, reports, and manufacturing records.Collaborate with cross-functional teams to address product and process quality issues.Support internal, customer, supplier, and regulatory audits.Ensure compliance with applicable quality standards, regulatory requirements, and company procedures.Drive continuous improvement initiatives to improve product quality, process performance, and operational efficiency.Provide guidance and mentorship to junior engineers and quality personnel. Qualifications Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.Experience in a quality engineering role within the medical device industry.Working knowledge of FDA Quality System Regulations, ISO 13485, and other applicable regulatory requirements.Experience with quality systems, CAPA, root cause analysis, and risk management methodologies.Familiarity with validation activities, including process, equipment, and test method validation.Strong problem-solving, analytical, and interpersonal communication skills.Ability to work effectively in a cross-functional, fast-paced environment. Preferred Qualifications Experience supporting both manufacturing and new product development activities.Knowledge of statistical analysis and quality tools.ASQ certifications or other relevant quality certifications.Experience working with suppliers and external manufacturing partners. Key Competencies Quality Systems ComplianceCAPA & Root Cause AnalysisRisk ManagementValidation & QualificationContinuous ImprovementData Analysis & Problem SolvingCross-Functional CollaborationAudit Support & Regulatory ComplianceTechnical Leadership and Mentorship