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.