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The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards. Essential Duties and Responsibilities: Quality System Management: Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485 and FDA regulations. Participate in internal and external audits, including preparing necessary documentation and follow-up on corrective actions. Validation and Verification: Design and execute validation protocols for new products and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Ensure all manufacturing processes, equipment, and materials meet pre-set quality standards. Risk Management: Conduct risk analysis and management throughout the product lifecycle in accordance with ISO 14971. Prepare and maintain Risk Management Files (RMF) for all products. Product Quality Assurance: Perform root cause analysis on product failures and implement corrective and preventive actions (CAPA). Review and approve product testing methods and final product releases. Supplier Quality Management: Work with suppliers to establish quality requirements for materials, components, and sub-assemblies. Conduct supplier audits and performance evaluations to ensure compliance with quality standards. Documentation and Reporting: Develop and maintain comprehensive documentation for quality assurance processes and procedures. Generate quality reports for management review, including trend analysis and quality performance metrics. Training and Leadership: Train and support production staff on quality assurance standards and practices. Lead cross-functional teams to address and resolve quality issues. Qualifications: Bachelor's degree in Engineering, Quality, or a related field. 3+ years of experience in quality engineering within the medical device industry. Strong understanding of FDA, ISO 13485, and other regulatory standards. Proficiency in statistical analysis software and Microsoft Office Suite. Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities.
