Quality Engineer

Virtue America; United States; On-site; USD 55,000 - 75,000; Full time

Job summary

Virtue America is seeking an Entry-Level Quality Engineer to support quality systems, manufacturing processes, investigations, documentation, and continuous improvement in a regulated pharmaceutical or life sciences environment.

You will collaborate with QA, QC, Manufacturing, Engineering, and Validation teams to ensure compliance with cGMP, FDA, and company quality standards, contributing to deviations, CAPA, change controls, and quality records.

Qualifications

• Bachelor's degree in a relevant engineering or life sciences field.
• Familiarity with QMS and pharmaceutical manufacturing.
• Fresh graduates or 0–2 years of experience encouraged.

Responsibilities

• Support quality engineering activities for pharmaceutical manufacturing processes, equipment, and systems.
• Assist deviations, CAPA, change controls, non-conformance management and investigations.
• Contribute to root-cause analysis using structured techniques.
• Prepare, review, and maintain SOPs, quality records, and investigation reports.
• Assist process improvement, equipment qualification, validation, and related activities.
• Collect and analyze quality data to identify trends and improvement opportunities.
• Support quality risk assessments and corrective and preventive actions.
• Ensure compliance with cGMP, FDA, GDP and quality requirements.
• Maintain audit readiness with complete quality records.
• Collaborate with QA, QC, Manufacturing, Engineering, and Validation teams.
• Participate in Lean, Six Sigma and continuous improvement initiatives.

Skills

QMS knowledge

cGMP knowledge

Root-cause analysis

Process validation

Data analysis

Communication skills

Cross-functional teamwork

0-2 years exp

Education

Bachelor's degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Pharmaceutical Engineering, Biotechnology, Life Sciences

Job description

We are seeking a detail-oriented and motivated Entry-Level Quality Engineer to support quality systems, manufacturing processes, investigations, documentation, and continuous improvement activities within a regulated pharmaceutical or life sciences environment. The role will work closely with QA, QC, Manufacturing, Engineering, and Validation teams to ensure compliance with cGMP, FDA, and company quality standards.

Key Responsibilities:

• Quality Engineering Support: Assist with quality engineering activities related to pharmaceutical manufacturing processes, equipment, and systems.
• Quality Systems: Support deviations, CAPA, change controls, non-conformances, and quality investigations.
• Root Cause Analysis: Assist with investigations using 5 Whys, Fishbone/Ishikawa, and other problem-solving techniques.
• Documentation Management: Prepare, review, and maintain SOPs, quality records, investigation reports, and technical documentation.
• Process & Equipment Support: Assist with process improvement, equipment qualification, validation, and quality-related engineering activities.
• Data & Trend Analysis: Collect and analyze quality data to identify trends, recurring issues, and opportunities for improvement.
• Risk Management: Support quality risk assessments and implementation of appropriate corrective and preventive actions.
• Regulatory Compliance: Ensure activities comply with cGMP, FDA, GDP, and applicable pharmaceutical quality requirements.
• Audit Readiness: Maintain accurate and complete quality records to support internal and external audits and regulatory inspections.
• Cross-Functional Collaboration: Work with QA, QC, Manufacturing, Validation, Engineering, and Production teams to resolve quality issues.
• Continuous Improvement: Participate in Lean, Six Sigma, process improvement, and operational excellence initiatives.

Required Skills:

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Pharmaceutical Engineering, Biotechnology, Life Sciences, or a related field.
• Basic understanding of Quality Management Systems (QMS) and pharmaceutical manufacturing.
• Familiarity with cGMP, SOPs, CAPA, deviations, change control, and non-conformance management.
• Basic knowledge of root-cause analysis, risk assessment, process validation, and quality documentation.
• Strong analytical and problem-solving skills with excellent attention to detail.
• Good written and verbal communication skills.
• Ability to work effectively with cross-functional teams in a regulated environment.
• Fresh graduates and candidates with 0-2 years of relevant experience are encouraged to apply.