Design Quality Engineer

Description

Job Summary: This role involves providing quality assurance for medical products, focusing on design controls, risk management, and regulatory compliance within a regulated industry. Key Responsibilities: 1. Support for significant quality issues and timely assessment of events 2. Partner with R&D to embed quality and manufacturability in new products 3. Ensure compliance with ISO 13485, FDA 21 CFR 820, and EU MDR Job Description and Detailed Activities * Provide escalation support for significant quality issues * Ensure timely assessment and containment of quality events * Partner with R&D to embed quality and manufacturability into new product designs * Support design controls for development and sustaining changes * Participate in design reviews with a strong focus on producibility and risk * Ensure design changes are manufacturable, verifiable, and compliant * Support verification & validation activities with production-representative builds * Support risk management (DFMEA, use-related risk, production risk inputs) * Investigate design-related production issues and quality escapes * Translate production floor feedback into actionable R&D design improvements * Ensure design documentation and traceability (DHF, requirements, V&V) are audit-ready * Support audits and inspections related to design controls * Participate in MRB activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material * Ensure sustained compliance with applicable regulations and standards, including ISO 13485, FDA 21 CFR 820 (QSR), EU MDR (as applicable), and relevant IEC standards (e.g., IEC 60601-1) * Collaborating with Supplier Quality and Supply Chain leadership on supplier-related quality issues Experience and Requirements * A/BS Degree, or equivalent combination of education and experience in a technical discipline is required * 3+ years of experience in Design Quality Engineering, Product Quality, or Manufacturing Quality within a regulated industry * Must have working knowledge of quality systems and practices * Must be able to provide guidance to functional teams on quality requirements * Experience in Quality Systems per ISO 13485 * Ability to work in a Project Team Environment * Direct experience supporting manufacturing of regulated medical products * Strong working knowledge of CAPA, nonconformance management, change control, and root cause analysis * Excellent verbal and written communication skills * Excellent prioritizing, organizational, and interpersonal skills * Excellent documentation skills including detail-oriented, record maintenance/tracking and understanding of document traceability Benefits * Superior Benefits to LFT **Number of Vacancies** 3 **Department** Quality **Contract Type** Permanent **Work Mode** On-site **Shift** Day Shift **Working Hours** Full-time **Schedule*** Monday to Friday 08:00-17:30 hrs **Education** Bachelor’s degree with professional title **English** Spoken: Advanced, Written: Advanced **Willingness to Travel** No