Principal Quality Engineer

The Principal Quality Engineer at Nextern will lead and innovate the quality assurance processes within the integrated systems and therapy delivery segments. This role is pivotal in fostering a culture of quality across the organization by establishing standards and practices that support regulatory compliance and product excellence. The Principal Quality Engineer will work closely with cross-functional teams to influence product design, improve processes, and ensure that quality objectives are achieved sustainably.

Key responsibilities include :

• Develop and implement quality strategies to support new product development, manufacturing processes, and supply chain management.
• Oversee and coordinate the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA regulations, and applicable international standards.
• Lead risk management activities, including FMEAs and risk assessments, to identify potential quality issues proactively.
• Facilitate collaboration among engineering, manufacturing, and supplier teams to drive continuous improvement initiatives and quality enhancements.
• Conduct complex investigations for non-conformances, CAPAs, and customer complaints, ensuring timely and effective resolution.
• Provide coaching and mentorship to quality engineers and cross-functional teams on quality tools and methodologies.
• Engage with regulatory agencies during audits and inspections, ensuring all quality practices are well-documented and compliant.

Requirements

PHYSICAL DEMANDS AND WORK ENVIORNMENT :

Benefits

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.