Mechanical Quality / Design Control Engineer (Pune)

Experience: 5-10 years / Band C Key Responsibilities - Design Control & - Documentation (NPD): Drive completion of Design History Files (DHF) from user needs to design outputs, ensuring compliance for current orthopedic product introductions. - Verification & - Validation (V&V;): Lead test protocol development and execution for biomechanical, sterilization, and material validation to confirm product performance. - Risk Management: Maintain the Risk Management File (ISO 14971), conducting FMEA and clinical risk assessments across the product lifecycle. - Life Cycle Management (LCM): Oversee sustaining engineering activities, including product modifications, line extensions, and engineering change requests (ECR/ECO). - Design Transfer: Collaborate with Manufacturing and Operations to ensure smooth, compliant transfer of designs into production. - Regulatory Support: Provide documentation for audits and regulatory submissions (FDA 510k, EU MDR) and participate in design reviews. - Process Improvement: Apply Lean and Six Sigma tools to improve design control processes, reduce defects, and enhance efficiency. - Quality & - Field Support: Conduct field inspections, calibration, PFMEA, and maintain field quality procedures/work instructions. - CAPA & - NonConformance: Support corrective/preventive actions, quality holds, and resolution of nonconformances. - Inspection & - Testing: Perform verification of finished goods, purchased products, and raw materials; conduct visual/dimensional inspections per GMP requirements. - Root Cause Analysis: Investigate issues, recommend corrective actions, and ensure preventive measures are implemented. - Training & - Mentorship: Train team members on inspection methods, equipment use, and quality systems. - CrossFunctional Collaboration: Partner with Quality Managers, Field Offices, Commercial Operations, and Distribution teams to support projects and quality initiatives. Required Qualifications - Bachelors degree in Mechanical, Biomedical, Manufacturing, or Industrial Engineering - 3+ years of quality or manufacturing engineering experience - Working knowledge of FDA QSR, ISO 13485, and ISO 14971 - Experience with inspections, technical drawings, and measurement equipment - Robust analytical, communication, and problem-solving skills - Proficiency with PC-based tools and quality documentation systems .

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