Quality Assurance Engineer

Reports To: Design Quality Engineering Manager Position Summary Responsible for supporting product development teams by implementing and maintaining quality systems that ensure compliance with company standards and regulatory requirements. Serves as the Quality Assurance representative during product development and sustaining engineering activities. Key Responsibilities Support new product development (NPD) and sustaining engineering projects Participate in design and manufacturing reviews Develop and maintain risk analyses (DFMEA / UFMEA) Review and approve design and development documentation Serve as design quality subject matter expert during ISO and FDA audits Author quality procedures and work instructions Conduct internal quality system audits Evaluate and disposition nonconforming materials Ensure compliance with GMP, ISO, FDA, and other regulatory standards Analyze device failures, complaints, and quality trends Lead Corrective and Preventive Actions (CAPA) and support Health Hazard Evaluations Minimum Qualifications Bachelor’s degree in Biomedical or Mechanical Engineering 5+ years experience in quality or product development Experience in a regulated industry (medical device, aerospace, automotive) Proficiency in Microsoft Office Preferred Qualifications Knowledge of ISO 13485 and ISO 14971 risk management Experience with SolidWorks, Oracle R12, Agile PLM CQE, Lean, or Six Sigma certification preferred Understanding of precision manufacturing and sterilization processes #J-18808-Ljbffr