Senior Advanced Quality Engineer

Work Flexibility: Hybrid **What you will do-** * Support New Product Development (NPD) Design Quality Engineering activities for orthopedic medical devices, with a primary focus on risk management, usability engineering and design control as per the project and business need. * Effectively collaborate with cross functional partners (Product Development, Regulatory Affairs, Quality, Clinical, Manufacturing, Packaging, Sterility, etc.  and ensure compliance with applicable Quality System and regulatory requirements throughout the development process. * Lead risk management and usability activities in accordance with applicable standards and internal procedures including formative and summative evaluations. Drive identification, assessment, and mitigation of product and process risks. * Drive continuous improvement initiatives and identify opportunities to improve quality, efficiency, and consistency of deliverables. **What you will need-** **Required skills-** * Bachelor's or master’s in mechanical engineering, bio-medical or similar domain. * Experience- 4 years -7 years * Experience of working in regulated environment such as FDA QSRs, ISO 13485 Design Control Procedures, IEC 62366-1, and ISO 14971 and experience with Product Lifecycle Management (PLM) tools, requirement management tools (Jama etc) and project management tools (JIRA etc) * Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing. **Preferred skills-** * Knowledge of EU Medical Device Regulation preferred * Familiarity with design reviews and Design History File (DHF) documentation creation and organization. * Experience with 3D CAD software, especially Creo from PTC and experience with surgical trays. Travel Percentage: 10%