Senior Quality Engineer - Product Development

Senior Quality Engineer supporting product leadership and risk management for new combination product development at a major medical technology company. The role encompasses design validation, process development, manufacturing transfer, and post-launch sustainability activities.

Responsibilities

• Lead development of risk assessments, test methods, and component qualifications
• Represent quality engineering on product development and design review teams
• Support translation of design inputs into manufacturing control plans and specifications
• Conduct product investigations and assess changes against product design specifications
• Provide regulatory support and prepare technical submissions; coordinate supplier audits

Requirements

• Bachelor's degree in Engineering
• Minimum five years medical device, pharmaceutical, or equivalent engineering experience
• Proficiency with quality engineering tools and statistical analysis methods
• Knowledge of risk management, design validation, process validation, and component qualification
• Understanding of regulatory standards including ISO 13485, ISO 14971, and 21 CFR 820
• Strong cross-functional leadership and interpersonal skills
• ASQ Quality Engineering Certification or equivalent (preferred)