Quality Systems Engineer

Position: Quality Systems Engineer

Location: Hazleton, PA (Onsite)

Type: Full-Time | Direct Hire

We are seeking a highly motivated Quality Systems Engineer to join our client’s team in Hazleton, PA. The ideal candidate will play a critical role in enhancing the Quality Management System (QMS), driving continuous improvement, and ensuring full compliance with industry standards.

Key Responsibilities:

• Lead the Self-Improvement Planning (SIP) process to support continuous enhancement of PFN’s Quality Management System (QMS).
• Develop and execute Internal Audit Plans aligned with industry quality standards and best practices.
• Establish and manage Corrective Action and Preventive Action (CAPA) programs, including defining metrics to measure progress and results.
• Perform periodic CAPA and Internal Audit reviews to ensure long-term corrective sustainability and compliance.
• Support External Audit preparation and participation, and coordinate follow-up CAPA activities when required.
• Compile, analyze, and maintain quality performance metrics to evaluate program effectiveness and identify improvement opportunities.

Required Skills & Experience:

• BS degree in Engineering, Technology, Mathematics, Business, or a science discipline.
• 5–10 years of experience in a technical role within a manufacturing environment.
• Proven experience with Internal & External Auditing against quality standards (ISO, EDANA, and/or GMP).
• Hands-on proficiency with Vision Systems setup, troubleshooting, and calibration.
• Strong communication, attention to detail, and organizational skills.

Warm Regards,

Andrew