Quality Engineer

Quality Engineer Key Responsibilities Maintain and improve the Quality Management System (QMS) to ensure compliance and operational effectiveness Manage QMS processes including Audits, CAPA, Document Control, and Training Analyze quality data, identify improvement opportunities, and support corrective actions Prepare for and support external audits and inspections Collaborate cross-functionally on quality planning, risk management, validation, and training initiatives Required Education & Experience Bachelor’s degree in Engineering, Science, Manufacturing, or related field 5+ years of experience in Quality Systems, Compliance, or Auditing within a regulated environment EU MDR Knowledge, Skills, & Abilities Strong knowledge of quality systems, regulatory compliance, and risk management Experience supporting audits and maintaining compliant processes Strong communication, analytical, and problem-solving skills Proficiency with Microsoft Office applications Preferred Qualifications Project management experience Lead Auditor or Quality Auditor certification Experience with software lifecycle or validation requirements Familiarity with international regulatory standards Benefits 401(k) Dental insurance Health insurance Paid time off #J-18808-Ljbffr