Senior Quality Engineer: Systems, Supplier & CI Lead

Pride Mobility & Quantum Rehab; Duryea (Luzerne County); On-site; USD 120,000 - 180,000; Full time

Job summary

Pride Mobility Products Corporation/Quantum Rehab is seeking a Senior Quality Engineer to provide technical leadership and strategic direction for quality initiatives across product, process, and supplier domains. You will drive QMSR compliance, CAPA, root cause analyses, and cross-functional improvements with R&D involvement.

The role requires extensive experience in regulated manufacturing, ISO 13485, FDA QMSR, and a proven track record of leading quality teams to improve product quality,

Qualifications

• Requires a Bachelor’s degree in Engineering or related field.
• Experience in regulated manufacturing environments preferred.
• Strong knowledge of quality systems and regulatory requirements (ISO 13485, FDA QMSR).
• Demonstrated leadership and mentorship in quality teams.

Responsibilities

• Lead quality leadership for QMSR implementation, CAPA, and regulatory compliance.
• Drive corrective and preventive actions and root cause analyses.
• Oversee supplier quality, supplier audits, and performance improvement initiatives.
• Collaborate with R&D to ensure regulatory compliance in new product development.
• Provide technical leadership in statistical analysis and quality improvement projects.
• Communicate metrics and improvements to management.

Skills

Multi-tasking

Problem-solving

Project management

Leadership

Cross-functional collaboration

Statistical analysis

Six Sigma

CAPA

Education

Bachelor’s Degree in Engineering

Tools

CAD drafting/modeling

Microsoft Word

Microsoft Excel

Job description

Pride Mobility Products Corporation/Quantum Rehab is seeking a Senior Quality Engineer to provide technical leadership and strategic direction for quality initiatives across product, process, and supplier domains. You will drive QMSR compliance, CAPA, root cause analyses, and cross-functional improvements with R&D involvement.

The role requires extensive experience in regulated manufacturing, ISO 13485, FDA QMSR, and a proven track record of leading quality teams to improve product quality,