Senior Quality Engineer

Job Summary

A company is looking for a Senior Development Quality Engineer-Medical Device.

Key Responsibilities

• Lead Quality Engineering activities for software and hardware product development, including design control and risk management
• Establish relationships with cross-functional teams to enhance development project success
• Provide guidance on statistical methods for design verification and validation, and oversee quality documentation

Required Qualifications

• 8+ years of Quality Engineering experience in the medical device industry
• B.S./M.S. in a relevant engineering field or equivalent scientific degree
• Experience with FDA regulations and ISO standards related to medical devices
• Knowledge of quality engineering tools and statistical analysis techniques
• Experience in design, development, and testing of medical device hardware and software