Staff Quality Compliance Engineer

Job description

Job responsibilities

• Lead and manage special projects for the Quality Compliance and Post-Market Surveillance team, including planning, execution, and delivery of strategic initiatives and continuous improvement efforts.
• Proactively identify process risks and improvement opportunities within the Quality Management System (QMS), leveraging a deep understanding of cross-functional interdependencies to implement sustainable, effective…
• Serve as a Quality Compliance and Post-Market Surveillance team representative on cross-functional initiatives, operating independently while influencing stakeholders and coordinating activities to meet project…
• Perform and lead Corrective and Preventive Actions (CAPA), including conducting thorough root cause investigations and developing corrective actions with appropriate scope and rigor relative to the identified quality…
• Define key performance requirements for processes and projects; establish monitoring mechanisms and evaluate effectiveness against defined objectives to ensure continuous improvement.
• Review and interpret regulations, standards, and guidance to ensure products, processes, and services remain compliant and aligned with state-of-the-art and regulatory expectations.
• Apply sound technical judgment, data-driven analysis, and pragmatic problem-solving within the constraints of applicable regulations, standards, and internal procedures.
• Drive cross-functional collaboration by effectively engaging subject matter experts and stakeholders to achieve aligned, timely outcomes.

Job requirements

• Bachelor’s degree in engineering, science, or another technical discipline.
• 8 years of progressive experience in a medical device industry, including at least 5 years in quality systems, quality engineering, and/or compliance roles.
• Working knowledge of FDA QSR/QMSR, ISO 13485, MDSAP, and EU MDR regulatory requirements.
• Working knowledge of computer software validation principles, including in-device software, GxP systems, and 21 CFR Part 11.
• Demonstrated ability to lead project teams and deliver results within aggressive timelines.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to clearly convey complex concepts to diverse audiences.
• Ability to apply conceptual and systems thinking to understand complex issues and downstream implications.