Quality Engineer - 173405

ZP Group; Raleigh (NC); On-site; USD 103,000 - 131,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Sick leave

401K

Job summary

Piper Companies is seeking a Quality Engineer for a contract role in the Raleigh, NC area to focus on investigations, CAPA execution, and compliance remediation within a GMP manufacturing environment.

The role requires strong root cause analysis skills, hands-on problem solving with operations teams, and a solid understanding of FDA/cGMP frameworks to strengthen inspection readiness and regulatory alignment. Position is on-site in Raleigh.

Qualifications

• Bachelor's degree in a technical field required.
• 5+ years in GMP-regulated manufacturing with investigations and CAPA.
• Strong knowledge of FDA regulations and deviation management.

Responsibilities

• Conduct investigations of deviations and quality events to determine root cause and product impact.
• Collaborate with production personnel and plant leadership to evaluate processes and address quality concerns.
• Lead CAPA activities and ensure timely closure per regulatory expectations.
• Support remediation initiatives from regulatory observations and quality system improvements.
• Perform on-site assessments to strengthen compliance and inspection readiness.

Skills

CAPA management

Root cause analysis

GMP manufacturing

Investigations

Education

Bachelor's degree in Engineering/ Chemistry/ QA/ Manufacturing/ Life Sciences

Job description

Piper Companies is seeking a Quality Engineer for a contract engagement supporting a regulated manufacturing operation in the Raleigh, North Carolina area. This Quality Engineer will focus on quality investigations, CAPA execution, and compliance remediation efforts within a GMP manufacturing environment as the organization continues strengthening inspection readiness and FDA compliance initiatives.

Responsibilities

• Conduct thorough investigations of deviations, nonconformances, and quality events to determine root cause and product impact within GMP manufacturing operations.
• Partner directly with production personnel and plant leadership to gather data, evaluate processes, and assess manufacturing-related quality concerns.
• Lead and author corrective and preventive action (CAPA) activities, ensuring timely closure and alignment with regulatory expectations.
• Support ongoing remediation initiatives stemming from previous regulatory observations and quality system improvement efforts.
• Perform on-site assessments of manufacturing processes, equipment, and operational controls to strengthen compliance and inspection readiness.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Quality Assurance, Manufacturing, Life Sciences, or a related technical field.
• 5+ years of experience supporting GMP-regulated manufacturing environments with a strong emphasis on investigations and CAPA management.
• Proven ability to perform hands‑on root cause analysis within manufacturing facilities and effectively partner with operations teams.
• Working knowledge of FDA regulations, cGMP requirements, quality systems, and deviation management processes.
• Experience within chemical manufacturing, specialty chemicals, pharmaceutical manufacturing, or other process‑driven production environments strongly preferred. Candidates whose backgrounds are primarily focused on biologics may be less aligned unless they possess significant traditional manufacturing experience.

Compensation

• Salary Range: $75/hr - $95/hr (flexibility available for highly qualified candidates with directly relevant experience)
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

Application Details

• Location: Raleigh, NC
• Work Schedule: On‑site, 5 days per week
• Employment Type: Contract (3-6 month engagement)
• Posting Date: 8/31/2026
• Apply By / Closing Date: Open Until Filled

Keywords

Quality Engineer, GMP, cGMP, CAPA, Corrective and Preventive Action, Deviation Investigation, Root Cause Analysis, FDA Compliance, Quality Systems, Manufacturing Quality, Chemical Manufacturing, Process Manufacturing, Regulatory Compliance, Nonconformance Management, Quality Assurance, FDA Audit, Inspection Readiness, Product Quality, Quality Event Investigation, Audit Remediation, Risk Assessment, Manufacturing Operations, Quality Engineering, GMP Facility, Process Investigation, Compliance Remediation, Quality Management System, QMS, Change Control, Technical Investigations, Continuous Improvement, Quality Documentation, Regulatory Inspections, Manufacturing Support, Quality Compliance, Plant Operations, Quality Metrics, Pharmaceutical Manufacturing, Process Excellence, FDA Readiness