Quality Engineer

Quality Engineer

Phoenix, AZ

We are seeking a Quality Engineer to support quality and compliance activities within pharmaceutical, biotechnology, and medical device manufacturing environments. The Quality Engineer will work with cross-functional teams to identify quality issues, investigate root causes, implement corrective actions, and support continuous improvement initiatives.

Key Responsibilities

• Support quality assurance and quality control activities in manufacturing environments.
• Investigate deviations, nonconformances, and quality issues.
• Lead or support Root Cause Analysis (RCA) and CAPA activities.
• Support Change Control and document change-related quality impacts.
• Review and maintain quality documentation, procedures, and records.
• Analyze quality and manufacturing data to identify trends and recurring issues.
• Support process and product improvement initiatives.
• Participate in internal and external audits and inspections.
• Work with Manufacturing, Engineering, Validation, and Regulatory teams to resolve quality issues.
• Ensure manufacturing and quality activities comply with applicable GMP, FDA, ISO, and company requirements.
• Support supplier quality activities, investigations, and supplier-related corrective actions when required.
• Assist with risk assessments and implementation of appropriate risk mitigation actions.
• Prepare quality reports, investigation summaries, and other technical documentation.

Required Qualifications

• Bachelor’s degree in Quality Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• Experience in Quality Engineering, Quality Assurance, Manufacturing, or a related role.
• Experience working in a Pharmaceutical, Biotech, Medical Device, or other regulated manufacturing environment.
• Knowledge of GMP, FDA regulations, and/or ISO quality standards.
• Experience with CAPA, deviations/nonconformances, Root Cause Analysis, and Change Control.

Preferred Qualifications

• Experience with medical device quality systems and ISO 13485.
• Knowledge of ISO 14971 and risk management.
• Experience with FDA 21 CFR Part 820/QMSR requirements.
• Experience with pharmaceutical GMP and 21 CFR Part 210/211.
• Familiarity with Lean Manufacturing, Six Sigma, or Continuous Improvement methodologies.
• Experience with validation, process improvement, or manufacturing engineering.
• Experience supporting FDA or other regulatory inspections.