Quality Engineer

Purpose of the role:

The Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance.

Roles & Responsibilities:

• Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366).
• Participate in design reviews and provide quality engineering support throughout the product development lifecycle.
• Establish and maintain Design History Files (DHF) and Risk Management Files (RMF).
• Conduct design verification and validation activities, ensuring product safety and efficacy.
• Develop and implement risk management activities including Failure Mode and Effects Analysis (FMEA).
• Collaborate with cross-functional teams to ensure effective design transfer from R&D to manufacturing.
• Support the creation and review of technical documentation, including design inputs/outputs, specifications, and reports.
• Manage non-conformances, CAPAs, and change management activities related to design quality.
• Provide guidance on regulatory requirements and standards related to orthopedic implant design.
• Participate in internal and external audits, including regulatory inspections.