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 activities within a regulated Pharmaceutical/Life Sciences environment. The role includes investigations, risk management, process improvement, validation support, and quality-system activities to ensure product quality and regulatory compliance.

You will collaborate with QA, QC, Manufacturing, Engineering, Validation, and Regulatory Affairs teams to monitor processes, analyze data, and assist with CAPA, change control,

Qualifications

• Bachelor’s or Master’s degree in Quality Engineering, Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Life Sciences, or a related field.
• Basic understanding of quality management systems and pharmaceutical manufacturing processes.
• Familiarity with cGMP, GDP, SOPs, deviations, CAPA, change control, and risk management.
• Knowledge of FMEA, root-cause analysis, and continuous improvement concepts.
• Basic understanding of validation and qualification activities is preferred.
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.
• Strong attention to detail and technical documentation skills.
• Proficiency with Microsoft Excel, Word, and PowerPoint; exposure to quality-management or data-analysis systems is a plus.

Responsibilities

• Quality Engineering Support: Monitor manufacturing and laboratory processes to identify quality risks and opportunities for improvement.
• Risk Management: Assist with risk assessments using FMEA, risk ranking, and process mapping.
• Investigation Support: Assist with investigations involving deviations, non-conformances, complaints, and process-related quality events.
• Root Cause Analysis: Participate in root-cause investigations using methodologies such as 5 Whys and Fishbone analysis.
• CAPA Management: Support the development, tracking, implementation, and effectiveness review of CAPA.
• Process Improvement: Analyze quality trends and data to identify opportunities for reducing defects, variability, and recurring issues.
• Validation Support: Assist with process validation, equipment qualification, cleaning validation, and continued process verification activities.
• Change Control: Support technical and quality assessments for changes involving processes, equipment, materials, and procedures.
• Quality Documentation: Prepare and review protocols, reports, investigation records, SOPs, and other controlled documents in accordance with GDP requirements.
• Data Analysis: Compile and analyze quality metrics, defect data, deviation trends, and process-performance information.
• Cross-Functional Collaboration: Work with QA, QC, Manufacturing, Engineering, Validation, and Regulatory Affairs teams to resolve quality issues.
• Compliance: Ensure assigned activities follow cGMP, FDA requirements, ISO quality principles, and site-specific procedures.

Skills

Analytical & problem-solving

Strong communication

Attention to detail

Quality management concepts

Education

Bachelor’s or Master’s degree in Quality/Engineering related field

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

We are seeking a motivated and detail-oriented Entry-Level Quality Engineer to support quality engineering activities within a regulated Pharmaceutical/Life Sciences environment. This role will assist with quality investigations, risk management, process improvement, validation support, and quality-system activities to help maintain consistent product quality and regulatory compliance.

Key Responsibilities:

• Quality Engineering Support: Assist with monitoring manufacturing and laboratory processes to identify potential quality risks and opportunities for improvement.
• Risk Management: Support quality risk assessments using tools such as FMEA, risk ranking, and process mapping.
• Investigation Support: Assist with investigations involving deviations, non-conformances, complaints, and process-related quality events.
• Root Cause Analysis: Participate in root-cause investigations using methodologies such as 5 Whys and Fishbone analysis.
• CAPA Management: Support the development, tracking, implementation, and effectiveness review of Corrective and Preventive Actions (CAPA).
• Process Improvement: Analyze quality trends and manufacturing data to identify opportunities for reducing defects, variability, and recurring issues.
• Validation Support: Assist with process validation, equipment qualification, cleaning validation, and continued process verification activities.
• Change Control: Support technical and quality assessments for changes involving processes, equipment, materials, and procedures.
• Quality Documentation: Prepare and review protocols, reports, investigation records, SOPs, and other controlled documents in accordance with GDP requirements.
• Data Analysis: Compile and analyze quality metrics, defect data, deviation trends, and process-performance information.
• Cross-Functional Collaboration: Work with QA, QC, Manufacturing, Engineering, Validation, and Regulatory Affairs teams to resolve quality issues.
• Compliance: Ensure assigned activities follow cGMP, FDA requirements, ISO quality principles, and site-specific procedures.

Required Skills:

• Bachelor’s or Master’s degree in Quality Engineering, Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Life Sciences, or a related field.
• Basic understanding of quality management systems and pharmaceutical manufacturing processes.
• Familiarity with cGMP, GDP, SOPs, deviations, CAPA, change control, and risk management.
• Knowledge of FMEA, root-cause analysis, and continuous improvement concepts.
• Basic understanding of validation and qualification activities is preferred.
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.
• Strong attention to detail and technical documentation skills.
• Proficiency with Microsoft Excel, Word, and PowerPoint; exposure to quality-management or data-analysis systems is a plus.