Quality Engineer - Pharma Logistics & Cold Chain

Provide analysis and reporting of quality related processes and participate in quality improvement processes. Provide guidance through the application of Business Process Engineering (BPE) and Quality Driven Management (QDM) techniques for value assessment and achievement of business outcomes. Support root cause analysis and correction actions of internal and customer CAPAs.

We are looking for a seasoned Quality Engineer with deep expertise in pharmaceutical logistics and cold chain operations to ensure compliance with global regulatory and industry standards. The ideal candidate will have experience supporting CEIV Pharma‑certified operations, applying WHO PQS standards, and conducting temperature mapping and validation activities across transportation and storage environments.

• Liaison with business stakeholders for Quality and perform root cause analysis, FMEA, risk assessment, and solutioning.
• Transforming business processes and operational tools to enable global excellence.
• Design and implement statistical process control as required in key processes to reduce quality variance.
• Create control plans, including process maps and work instructions, for new products, processes, and projects.
• Conduct periodic process audits to ensure capabilities and stability to business outcomes.
• Participate in the planning, design, and implementation of quality assurance and process improvement efforts.
• Provide regular reporting on project plans, communication plans, and project status to all stakeholders.
• Performs other duties as assigned.

• Support and maintain the Quality Management System (QMS) to meet GDP, CEIV Pharma, and ISO 9001 standards for pharmaceutical transport and cold chain logistics.
• Lead or support temperature mapping and validation of cold chain lanes, vehicles, packaging systems, and storage areas in alignment with WHO PQS and regulatory expectations.
• Participate in CEIV Pharma audits, ensuring ongoing compliance and alignment with IATA standards for pharmaceutical air freight.
• Interpret and apply WHO Performance, Quality and Safety (PQS) guidelines for equipment and process control in global health supply chains.
• Deliver training and coaching to operations staff on temperature‑sensitive handling, GDP requirements, and audit preparedness.

Bachelor's degree/equivalent in Engineering, Business, Transportation or related discipline.

Two (2) years' professional experience required in applied engineering concepts and technology with experience in healthcare quality in manufacturing, laboratories or distribution or closely related fields.

• Working knowledge of Six Sigma and Lean Manufacturing concepts.
• Familiarity of Quality System Standards such as GxP, ISO 9001/ TL9000 requirements.
• Time management and organizational skills necessary to manage projects, prioritize workload, plan for resources to meet deadlines and goals and respond to day‑to‑day functional needs.
• Experienced with Microsoft Office software and web‑based applications.
• Strong verbal and written communication skills.
• Strong analytical skills.
• Excellent interpersonal skills with the ability to interact with and influence all levels within the organization.
• Customer service driven.
• Ability to champion improvement through anticipation and identification of problems and development of effective and efficient solutions.

None.

Certifications in GDP, ISO 9001 Lead Auditor, ASQ CQE, or CEIV Pharma. Experience with global health organizations, vaccines, or biologic distribution. Familiarity with QMS platforms, data loggers, IoT temperature monitoring, and thermal packaging validation. Skilled in Microsoft Project, Smartsheet/Asana/, Gantt Charts, RACI Matrices, Pareto Analysis, and DMAIC.

$5,364.26/mo – $11,801.37/mo (CO: $5,364.26/mo – $11,309.65/mo, CA: $5,662.27/mo – $9,476.86/mo, NJ: $5,662.27/mo – $9,059.63/mo, OH & VT: $5,662.27/mo – $9,342.75/mo, MN: $5,662.27/mo – $10,817.92/mo, IL & NV: $5,662.27/mo – $11,309.65/mo, MD, NY & WA: $5,662.27/mo – $11,801.37/mo, MA: $5,960.29/mo – $11,801.37/mo,…