Quality Engineer

GxP Associates; Pennsylvania; On-site; USD 60,000 - 85,000; Full time

Job summary

GxP Associates is seeking a detail-oriented Quality Engineer to support quality systems, manufacturing operations, process improvement, and compliance activities in a regulated environment. The role involves investigations, root cause analysis, CAPA, NCR, RCA, and ongoing quality documentation review, with collaboration across Manufacturing, Engineering, Operations, and Quality teams.

Candidates should have a Bachelor's degree in Engineering and 0–3 years of experience, with strong analytical

Qualifications

• Bachelor's degree in Quality/Engineering field required.
• 0–3 years of quality, manufacturing, or engineering experience.
• Familiarity with CAPA, NCR, RCA and nonconformance processes preferred.
• Knowledge of ISO 9001, ISO 13485, or GMP is a plus.
• Strong analytical and communication skills.
• Proficiency with Microsoft Office; Excel experience preferred.

Responsibilities

• Support day-to-day quality engineering activities within manufacturing operations.
• Assist with investigations related to nonconformances, defects, and quality issues.
• Support root cause analysis and corrective and preventive action activities.
• Assist with process and product quality improvement initiatives.
• Review manufacturing and quality documentation for accuracy and compliance.
• Support inspection, testing, and measurement activities.
• Assist with quality metrics, trend analysis, and reporting.
• Participate in internal audits and continuous improvement activities.
• Support supplier quality and incoming inspection activities as needed.
• Collaborate with Manufacturing, Engineering, Operations, and Quality teams.

Skills

Analytical skills

Communication

Quality engineering

Education

Bachelor's degree in Engineering

Job description

We are seeking a detail-oriented Quality Engineer to support quality systems, manufacturing operations, process improvement, and compliance activities. The ideal candidate will have a strong engineering foundation and an interest in quality engineering within a manufacturing or regulated environment.

Key Responsibilities

• Support day-to-day quality engineering activities within manufacturing operations.
• Assist with investigations related to nonconformances, defects, and quality issues.
• Support root cause analysis and corrective and preventive action activities.
• Assist with process and product quality improvement initiatives.
• Review manufacturing and quality documentation for accuracy and compliance.
• Support inspection, testing, and measurement activities.
• Assist with quality metrics, trend analysis, and reporting.
• Participate in internal audits and continuous improvement activities.
• Support supplier quality and incoming inspection activities as needed.
• Collaborate with Manufacturing, Engineering, Operations, and Quality teams.

Qualifications

• Bachelor's degree in Quality Engineering, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or related field.
• 0–3 years of experience in quality, manufacturing, or engineering.
• Basic understanding of quality tools and problem-solving methodologies.
• Familiarity with CAPA, NCR, RCA, or nonconformance processes is preferred.
• Knowledge of ISO 9001, ISO 13485, or GMP is a plus.
• Strong analytical and communication skills.
• Proficiency with Microsoft Office; Excel experience preferred.

Quality Engineering | CAPA | NCR | Root Cause Analysis | Corrective Action | SPC | FMEA | ISO 9001 | ISO 13485 | Continuous Improvement