Quality Engineering Project Manager

The Quality Engineering Project Manager oversees quality engineering within operations, leading a team to support manufacturing and compliance activities.

• Quality engineering expertise
• Validation and qualification
• Risk management activities
• cGMP knowledge
• Statistical quality systems
• Electronic document management
• Laboratory information management
• Physical and chemical characteristics
• Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial, Manufacturing, Electrical, or related discipline), Quality Engineering, or a related scientific field.
• Lead quality engineering activities to support manufacturing operations, product quality, and regulatory compliance.
• Manage quality engineering projects from planning through execution, ensuring timelines, budgets, and quality objectives are achieved.
• Develop, implement, and continuously improve Quality Management System (QMS) processes and procedures.
• Oversee equipment, process, cleaning, and computer system validation activities, including IQ/OQ/PQ documentation.
• Provide technical leadership for investigations involving deviations, non-conformances, out-of-specification (OOS) results, and customer complaints.
• Drive root cause analysis using quality tools such as 5 Whys, Fishbone Diagrams, and Failure Mode and Effects Analysis (FMEA).
• Lead and support CAPA (Corrective and Preventive Action) activities to ensure effective resolution and continuous improvement.
• Perform quality risk assessments and implement risk mitigation strategies in accordance with regulatory requirements.
• Collaborate with Manufacturing, Engineering, Validation, Regulatory Affairs, Supply Chain, and R&D teams to ensure product quality and process robustness.
• Ensure compliance with FDA regulations, cGMP, ISO standards, and other applicable regulatory requirements.
• Support internal, customer, and regulatory inspections and audits by preparing documentation and addressing audit observations.
• Review and approve validation protocols, technical reports, engineering change requests, and quality documentation.
• Analyze quality metrics and statistical data to identify trends and recommend process improvements.
• Lead process improvement initiatives using Lean, Six Sigma, or other continuous improvement methodologies.
• Ensure timely completion of quality documentation within Electronic Document Management Systems (EDMS) and Laboratory Information Management Systems (LIMS), where applicable.
• Monitor project milestones, identify risks, and communicate project status to stakeholders and senior management.
• Mentor and provide technical guidance to Quality Engineers and cross-functional team members.
• Support supplier quality activities, including qualification, audits, and issue resolution when required.
• Participate in new product introductions (NPI), technology transfers, and manufacturing scale-up activities.
• Maintain compliance with company quality policies, safety procedures, and industry best practices.