01Overview
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 .
