Development Quality Engineer

A company is looking for a Development Quality Engineer.

Key Responsibilities

Provide design quality engineering support to new product development teams, ensuring compliance with regulations and quality standards

Lead and support the completion of design control deliverables, verification and validation testing, and documentation for U.S. and EU market submissions

Manage risk activities, develop and validate test methods, review quality documentation, and collaborate with cross-functional partners throughout the product lifecycle

Required Qualifications

Bachelor's Degree in Engineering or a Technical Field is required

5+ years of engineering experience in quality, design verification, and / or product development is required

Experience in the medical device industry with knowledge of design control and regulatory standards (ISO 13485, ISO 14971) is required

Experience in test method development, validation, and risk documentation (FMEA, risk assessments) is required

Experience with electro-mechanical or implantable devices is preferred