Sr Design Quality Engineer

Responsibilities

• Serve as the Quality representative on cross-functional project teams, ensuring Design Control principles are effectively applied to product and process changes as well as new product development activities.
• Provide Quality Assurance leadership and guidance to project teams and within the Quality organization.
• Author, review, and approve Quality System documentation, including CAPAs, audit reports, and related quality records.
• Develop, review, and approve product quality documentation, including Design History Files (DHFs) and other design control deliverables.
• Create, review, and approve validation protocols and reports for products, processes, software, and stability studies.
• Lead and support risk management activities, including the development and review of FMEA, FMECA, FTA, and other risk assessment documentation.
• Analyze product and process nonconformances, determine root causes, and drive robust corrective and preventive action (CAPA) plans.
• Perform internal and supplier quality system audits to ensure compliance with regulatory and quality standards.
• Review and investigate product complaints, supporting timely resolution and continuous improvement efforts.
• Monitor, track, and trend key quality metrics and indicators to identify risks and improvement opportunities.
• Partner closely with manufacturing sites and other division facilities to ensure consistent quality practices and compliance across operations.
• Serve as an independent Quality Assurance reviewer and chair Design Reviews to ensure objective evaluation of product development activities.
• Mentor and develop quality professionals, technicians, and engineers through coaching, knowledge sharing, and technical guidance.
• Provide oversight and supervision for technicians and engineers, supporting performance, development, and project execution.
• Maintain awareness of evolving industry trends, regulations, and best practices through participation in professional organizations and industry forums, and communicate relevant insights to the business.

Required Qualifications

• BS/MS Engineering (BME or EE or ME)
• 5 years of experience in FDA regulated environment
• 3 years of product design experience
• 2 years of Quality Engineering experience in a regulated environment

Knowledge and Skills

• Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
• Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA
• Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability
• Demonstrated history of successfully interpreting regulations, and procedures
• Demonstrated skill in statistical analysis and applied statistical methodologies

Preferred Qualifications

• ASQ Certification