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 $110,000 - 160,000 annually
- 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.
Top Skills
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
