Field Service Quality Engineer

Title: Service Quality Engineer Hiring Organization: Connexion Systems & Engineering Compensation, Benefits, and Employment Type Duration: full-time, direct hire Pay rate: $100,000 - $125,000 + 12% annual bonus Job Location: Newark, DE Work Authorization: Must be authorized to work in the U.S. without sponsorship Relocation: Available for the right candidate Job#: bh18970 Description: We are seeking a Service Quality Engineer to play a critical role in building and strengthening a global service quality program within a highly regulated medical device environment. This position sits at the intersection of quality, engineering, and field service operations, ensuring that service activities are compliant, efficient, and consistently audit-ready. This is not a traditional manufacturing quality role—this position is focused on field service quality, supporting service teams and improving the performance, reliability, and compliance of installed systems in the field. You will be part of a high-impact initiative to elevate quality systems, working cross-functionally to drive improvements in service delivery, reduce costs, and enhance customer experience. What You'll Do Investigate service-related failures and defects using root cause analysis, statistical tools, and data trends Improve service processes, procedures, and standard work to ensure consistency, reliability, and regulatory compliance Partner with Field Service, Engineering, Operations, and Regulatory teams to resolve issues and prevent recurrence Monitor and analyze key service metrics (uptime, failure rates, cost, customer feedback) to drive continuous improvement Support CAPAs, audits, and non-conformance investigations Enhance installation quality, including first pass yield and early defect detection Analyze returned materials and service data to identify trends and implement corrective actions Contribute to quality system improvements, reporting, and documentation control Help ensure readiness for internal and external audits Collaborate with field teams (including shadowing Field Service Engineers initially) to better understand real-world service challenges What We're Looking For Bachelor's degree in Engineering (Mechanical, Electrical, Software, or related); advanced degree preferred 5–8+ years of experience in quality engineering within a medical device or regulated industry Strong experience supporting field service operations (this is a must-have) Hands-on experience with: Root cause analysis and problem-solving methodologies CAPA processes and non-conformance investigations Statistical analysis and quality tools Working knowledge of ISO 9001, ISO 13485, and GMP regulations Proven ability to work cross-functionally and influence without direct authority Strong communication skills with the ability to present data, insights, and recommendations Experience supporting or leading quality audits Ability to manage multiple priorities in a fast-paced, evolving environment Preferred Qualifications ASQ Certified Quality Engineer (CQE) or similar certification Lean Six Sigma (Green Belt or Black Belt) Lead Auditor certification Experience with installation quality, field returns, or service lifecycle processes Why This Role? High-visibility role with direct impact on quality transformation initiatives Opportunity to shape and improve service quality systems from the ground up Collaborative environment working with leadership and cross-functional teams Strong growth potential within a critical function of the organization If you have a background in field service quality within medtech and enjoy solving complex problems while driving meaningful improvements, this is an opportunity to make a lasting impact. You can review our other job postings at www.jobs.csetalent.com. Connexion's mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.