Quality Engineer (Med Device)

Direct Hire Service Quality Engineer

$105k - $130k (Some flex depending on exp.)

Newark, DE

We are seeking a Service Quality Engineer to support a global service organization in ensuring compliance with established quality processes, procedures, and regulatory requirements. This role is responsible for driving quality initiatives, improving service reliability, and supporting continuous improvement efforts across service operations.

The ideal candidate will bring strong technical and analytical experience, with the ability to evaluate complex issues, identify process improvements, and collaborate cross-functionally to enhance overall service performance and customer satisfaction.

Essential Responsibilities:

• Analyze complex issues and data sets requiring in-depth evaluation and independent judgment
• Develop, improve, and maintain standard work instructions, service processes, procedures, and systems
• Drive initiatives focused on improving service efficiency, reliability, and repeatability
• Implement methods for inspecting, testing, and evaluating service quality and performance
• Investigate quality standards, compliance requirements, and process improvements
• Support installation quality initiatives aimed at improving first-pass yield and reducing failures
• Perform defect analysis using statistical quality and process improvement methodologies
• Lead efforts related to identifying, preventing, and resolving non-conformances
• Monitor and analyze quality metrics, trends, and service performance data
• Collaborate with cross-functional teams including Operations, Engineering, Regulatory, and Quality to support corrective and preventive actions (CAPAs)
• Conduct root cause investigations and develop corrective action plans
• Support material review processes and help reduce service-related quality issues
• Prepare reports, maintain documentation, and support documentation control systems
• Lead and participate in internal and external quality audits
• Communicate quality concerns and resolutions with field service and operational teams
• Support vendor quality initiatives and assist with evaluating service providers
• Manage multiple projects while balancing timelines, priorities, and budget considerations
• Verify process improvements through data analysis and measurable performance results
• Support organization-wide quality and continuous improvement initiatives
• Perform additional responsibilities as needed

Required Qualifications:

• Bachelor’s degree in Engineering (Electrical, Mechanical, Software, Computer Engineering, or related field) required; Master’s degree preferred
• 5–8 years of related industry experience in quality engineering or service quality environments
• Quality Engineer certification preferred
• Strong understanding of process improvement methodologies and problem-solving techniques
• Experience developing procedures, work instructions, and quality documentation
• Ability to manage multiple priorities and projects in a fast-paced environment
• Strong organizational, analytical, and communication skills
• Knowledge of ISO 9001, ISO 13485, and GMP regulations
• Familiarity with design controls, inspection methods, and quality systems
• Experience conducting root cause analysis and resolving non-routine quality issues
• Ability to influence and collaborate effectively across teams and departments
• ASQ, RAPS, Lead Auditor, and/or Lean Six Sigma certifications are considered a plus