Senior Advanced Quality Engineer

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-

• Bachelors or masters 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.