Quality Engineer

Job DescriptionThe Quality Engineer I plays a key role in maintaining product quality, compliance, and process control for medical device manufacturing. This position ensures adherence to regulatory standards, drives continuous improvement initiatives, and supports post-market surveillance activities. The engineer collaborates with cross-functional teams to investigate product and process issues, develop risk-based solutions, and ensure ongoing product conformance and customer satisfaction.Responsibilities Develop and execute quality and control plans to ensure product conformance and manufacturing continuity. Lead investigations into production and customer quality issues to determine root cause and implement corrective and preventive actions (CAPA). Perform hands-on troubleshooting of manufacturing nonconformities and customer-returned devices. Monitor and analyze product performance using statistical and risk-based methodologies. Prepare and maintain technical documentation related to investigations, nonconformities, and complaints. Communicate complex technical issues and solutions effectively to internal stakeholders. Ensure compliance with Quality System Regulations (QSR), company policies, and applicable international standards (FDA, ISO 13485, etc.). Support audits, inspections, and continuous improvement initiatives. Participate in cross-functional quality projects and contribute to risk management and process improvement activities. Requirements: Bachelor's degree in engineering (Biomedical, Mechanical, Electrical, or related discipline). Minimum 2 years of relevant experience in a regulated industry (medical device or FDA environment preferred). Strong knowledge of FDA regulations, including 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 803 (Medical Device Reporting). Familiarity with ISO 13485 standards and other applicable regulatory requirements. Proficiency in root cause analysis, risk management, and quality tools (FMEA, CAPA, 8D, etc.). Excellent communication, analytical, and problem-solving skills. Proficient in project management and data analysis techniques. Experience in post-market surveillance or complaint handling. Working knowledge of statistical software or data visualization tools. Green Belt or Lean Six Sigma certification.