Staff (Quality Engineer 5) - New Product Development

Staff-level quality engineer position leading enterprise-wide quality initiatives and strategic projects at a medical device company. The role involves establishing quality frameworks, managing critical investigations and audits, and mentoring senior engineers while ensuring regulatory compliance across business units.

Responsibilities

• Lead cross-business unit quality initiatives and establish company-wide standards and frameworks
• Own escalation and resolution of high-impact product quality, compliance risks, and critical investigations
• Oversee design control activities, risk management files, and design verification/validation for new products
• Author, review, and approve quality documentation; lead critical CAPA and audit activities
• Mentor and develop junior and senior engineers into future Staff-level leaders

Requirements

• Minimum 12 years medical device quality engineering or QA experience
• Bachelor's degree in engineering or relevant discipline
• Advanced understanding of quality principles, methodologies, and evolving standards
• Expert data analysis and quality issue resolution capabilities
• Strong mentoring ability and executive presence to influence stakeholders
• Deep knowledge of design controls, risk management, and regulatory requirements (GMP, ISO, FDA)