Principal Quality Engineer

Nextern • Full-time • Maple Grove, MN, US • $110,000 - $160,000 / year • 3m ago

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

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
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

PHYSICAL DEMANDS AND WORK ENVIORNMENT:

Occasionally required to stand
Occasionally required to walk
Occasionally required to sit
Occasionally required to utilize hand and finger dexterity
Required to talk or hear
While performing the duties of this job, the noise level in the work environment is usually moderate to low
The employee must occasionally lift and /or move more than 25 pounds

Benefits

The expected salary for this position is $90,130-$100,000
Health Care Plan (Medical, Dental & Vision)
Retirement Plan with Company Match
Paid Time Off, Personal Days, AND Birthday Holiday!
Lifetime Membership Subsidy and Wellness Resources
Life Insurance (Basic, Voluntary & AD&D)
Family Leave (Maternity, Paternity)
Short-Term & Long-Term Disability
Taco Thursdays!!!

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.