Description

You will lead design control activities and ensure compliance with FDA and international regulations.

Responsibilities

• Lead design review meetings and participate in Design Failure Modes and Effects Analysis (DFMEA).
• Oversee verification and validation (V&V) planning, including IQ/OQ/PQ and MSA for internal processes.
• Manage nonconformances (NCs) and drive corrective and preventive actions (CAPA).
• Coordinate process validations and capability studies with Manufacturing Engineers.
• Execute supplier qualification processes, including supplier contracts and PPAPs.
• Support complaint investigations and interface with Regulatory Affairs for UL, IEC, and FDA submissions.
• Participate in internal audits and regulatory agency inspections.

Required Skills

• 8+ years of experience in medical device quality engineering or a related field.
• Bachelor’s degree in Engineering, Quality, or a related field.
• Expertise in ISO 13485, FDA QSR (21 CFR Part 820), and EU MDR.
• Deep understanding of risk management (ISO 14971).
• Hands-on experience with Design Control and Process Validation.
• Proficiency in CAPA and Supplier Quality management.
• Practical knowledge of DFMEA and Risk Management.

Key Skills

Education

Bachelor's degree