Principal Quality Engineer

Nextern•Maple Grove, MN

23d•$90,130 - $100,000

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Quality Assurance, or related field; a Master's degree is preferred.
8+ years of experience in quality engineering within a regulated industry, specifically medical devices.
Strong understanding of quality management systems (QMS) and regulatory requirements (ISO 13485, FDA, etc.).
Proven experience in risk management and process validation; familiarity with statistical process control and Six Sigma methodologies.
Demonstrated leadership ability with experience managing teams and cross-functional projects.
Excellent problem-solving skills and proficiency in quality tools (e.g., CAPA, FMEA, root cause analysis).
Strong communication skills with the ability to influence and advocate for quality at all organizational levels.

Nice To Haves

Knowledge of product development processes and methodologies is highly desirable.
Experience with quality management software and data analysis tools (e.g., Minitab, Excel, Agile PLM) is a plus.

Responsibilities

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.