Quality Engineer

Job Responsibilities:

• Support and maintain quality systems to ensure compliance with cGMP regulations, FDA requirements, and internal quality standards
• Collaborate with Manufacturing, Engineering, Validation, and Regulatory teams to support quality and compliance initiatives
• Investigate deviations, non-conformances, customer complaints, and quality events to determine root cause and implement corrective actions
• Lead and support CAPA activities to improve manufacturing processes and prevent recurring quality issues
• Review and approve manufacturing documentation including batch records, SOPs, protocols, and technical reports
• Perform risk assessments and participate in Process Failure Mode and Effects Analysis (FMEA) activities to identify and mitigate process risks
• Monitor manufacturing processes and quality metrics to identify trends and drive continuous improvement initiatives
• Support internal audits, supplier audits, customer audits, and regulatory inspections
• Ensure data integrity and accuracy of quality documentation, records, and electronic systems
• Assist with validation and qualification activities including process validation, equipment qualification, and cleaning validation reviews
• Support change control processes by evaluating the impact of proposed changes on product quality and regulatory compliance
• Partner with cross-functional teams to implement process improvements and enhance product quality and operational efficiency
• Develop and maintain quality procedures, work instructions, and compliance documentation
• Provide quality oversight and support for manufacturing operations in fast-paced GMP environments
• Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field
• 3+ years of experience in pharmaceutical, biologics, medical device, or GMP-regulated manufacturing environments
• Strong knowledge of cGMP regulations, FDA requirements, and pharmaceutical quality systems
• Experience with deviation investigations, CAPA systems, change controls, and quality risk management
• Familiarity with process validation, equipment qualification, and manufacturing operations preferred
• Understanding of aseptic processing, sterile manufacturing, or pharmaceutical production operations preferred
• Experience supporting audits, inspections, and regulatory compliance activities
• Strong analytical, troubleshooting, and problem-solving skills
• Excellent technical writing, documentation, and communication abilities
• Knowledge of risk management tools such as FMEA preferred
• Lean Six Sigma certification or continuous improvement experience preferred
• Ability to manage multiple priorities and work effectively in cross-functional teams
• Proficiency with Microsoft Office, quality systems, and electronic documentation systems preferred
• Strong attention to detail and commitment to maintaining high-quality standards