Quality Engineer - 173405

Piper Companies; Raleigh (NC); On-site; USD 103,000 - 131,000; Full time

Job summary

Piper Companies is seeking a Quality Engineer for a contract engagement in the Raleigh, NC area. The role focuses on quality investigations, CAPA execution, and compliance remediation within a GMP manufacturing environment to strengthen inspection readiness and FDA compliance initiatives.

The successful candidate will collaborate with production and plant leadership, perform root cause analyses, and drive CAPA closure to meet regulatory expectations in a dynamic manufacturing setting.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Quality Assurance, Manufacturing, Life Sciences, or related field.
• 5+ years in GMP‑regulated manufacturing with investigations and CAPA.
• Hands‑on root cause analysis in manufacturing facilities with operations collaboration.
• Knowledge of FDA regulations, cGMP, quality systems, and deviation management processes.

Responsibilities

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

Skills

Investigations

CAPA management

Root cause analysis

GMP / cGMP

Deviation management

Regulatory compliance

Education

Bachelor's degree in Engineering/Science

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