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 setting 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.