Sr. Quality Engineer North Haven, CT (Onsite) fulltime

About the role

Provide technical leadership and daily manufacturing support for multiple product families within manufacturing operations.

Responsible for maintaining and improving product quality, reducing manufacturing costs, optimizing manufacturing processes, and ensuring compliance with safety and regulatory requirements.

Partner with Production, Quality, Operations, Supplier Quality, and Engineering teams to investigate manufacturing issues, perform root cause analysis, qualify components, implement corrective actions, and drive continuous improvement initiatives.

Responsibilities

• Support process validation activities
• Manufacturing process development
• Equipment improvements
• Operational excellence projects

Requirements

• Strong problem-solving, manufacturing process knowledge, project management, technical communication, and leadership skills are required.
• Experience with Lean Manufacturing, Six Sigma, CAPA, PFMEA, and medical device quality systems is highly desirable.

Qualifications

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related Engineering discipline.
• 7+ years of Experience in manufacturing engineering within medical devices or other regulated industries.
• Strong knowledge of manufacturing processes, process validation, quality systems, and regulatory requirements.
• Experience with root cause investigations, process improvements, and cross-functional project execution.
• Leverage Lean Manufacturing and Six Sigma experience preferred.