Senior Quality Engineer: Lead Quality Systems & CI

RiseMe; Duryea (Luzerne County); On-site; USD 81,000 - 99,000; Full time

Job summary

Pride Mobility Products Corporation is seeking a Quality Engineering leader to direct quality systems, supplier quality, and regulatory compliance initiatives. You will guide CAPA, audits, and improvement projects to ensure product quality and process excellence.

Responsibilities include leading QMS improvements, collaborating with R&D and operations, and ensuring regulatory readiness while driving measurable quality outcomes across the organization.

Qualifications

• Bachelor’s Degree in Engineering or a related field.
• 5+ years of experience in Quality Engineering or a related field.
• Experience with regulatory compliance in medical devices (ISO 13485, FDA QMSR).
• Strong CAPA, nonconformance, and audit experience.
• Lean Six Sigma and problem-solving expertise required.

Responsibilities

• Provide technical leadership for quality initiatives and systems.
• Lead and improve QMS processes per FDA QMSR and ISO 13485.
• Manage CAPA, audits, and supplier quality activities.
• Collaborate with R&D, Purchasing, and Operations on quality objectives.
• Present quality metrics and improvement plans to leadership.

Skills

Quality engineering

Regulatory compliance

Auditing

CAPA/root cause analysis

Lean Six Sigma

Cross-functional leadership

Problem solving

Education

Bachelor’s Degree in Engineering or related field

Tools

CAD

MS Office (Word, Excel)

Quality tools (DMAIC, Six Sigma)

Job description

Pride Mobility Products Corporation is seeking a Quality Engineering leader to direct quality systems, supplier quality, and regulatory compliance initiatives. You will guide CAPA, audits, and improvement projects to ensure product quality and process excellence.

Responsibilities include leading QMS improvements, collaborating with R&D and operations, and ensuring regulatory readiness while driving measurable quality outcomes across the organization.