Mechanical Quality / Design Control Engineer

Cyient; Maharashtra; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Cyient is seeking a Quality Engineer in Maharashtra, India, to oversee design control and documentation, lead verification and validation testing, maintain risk management files, and ensure regulatory compliance for orthopedic product introductions. The ideal candidate will have a Bachelor's degree in Mechanical or related fields, along with over 3 years of engineering experience, strong analytical skills, and proficiency with quality documentation systems. A competitive salary and benefits package will be provided.

Qualifications

• 3+ years of quality or manufacturing engineering experience.
• Working knowledge of FDA QSR, ISO 13485, and ISO 14971.
• Experience with inspections and technical drawings.

Responsibilities

• Drive completion of Design History Files (DHF) for new orthopedic products.
• Lead test protocol development for verification and validation.
• Maintain the Risk Management File and conduct risk assessments.

Skills

Quality engineering

FDA QSR knowledge

Analytical skills

Problem-solving skills

Education

Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or Industrial Engineering

Tools

Quality documentation systems

Measurement equipment

Job description

• Design Control & Documentation (NPD): Drive completion of Design History Files (DHF) from user needs to design outputs, ensuring compliance for new 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 & Non‑Conformance: Support corrective/preventive actions, quality holds, and resolution of non‑conformances.
• 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.
• Cross‑Functional Collaboration: Partner with Quality Managers, Field Offices, Commercial Operations, and Distribution teams to support projects and quality initiatives.

Required Qualifications

• Bachelor’s 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
• Strong analytical, communication, and problem-solving skills
• Proficiency with PC-based tools and quality documentation systems