Senior Healthcare Quality Engineer

Description

Position Overview:

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.

Key Responsibilities:

· 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.

· Analyze and respond to temperature excursions and deviations, performing structured root cause analysis and implementing effective CAPAs.

· Prepare and maintain validation protocols, reports, and mapping records for audits and client reviews.

· Participate in CEIV Pharma audits, ensuring ongoing compliance and alignment with IATA standards for pharmaceutical air freight.

· Conduct vendor and carrier qualification audits, including risk assessments, technical evaluations, and QTA development.

· Interpret and apply WHO Performance, Quality and Safety (PQS) guidelines for equipment and process control in global health supply chains.

· Collaborate cross-functionally to implement risk-based controls, corrective actions, and improvements to cold chain operations.

· Generate and manage controlled documentation, including SOPs, work instructions, deviation reports, and training guides.

· Deliver training and coaching to operations staff on temperature-sensitive handling, GDP requirements, and audit preparedness.

· Design, implement, and optimize processes for pharmaceutical clients, with a focus on temperature-sensitive products and regulatory compliance.

· Conduct process mapping, time studies, and data analysis to identify inefficiencies and recommend improvements. PFMEA,

· Support customer onboarding and solution design, including RFQ responses, SOP development, and KPI definition.

· Collaborate with Quality, Operations, and IT teams to implement process improvements.

· Perform root cause analysis and corrective action planning related to cold chain excursions or supply disruptions.

· Stay up-to-date with pharmaceutical regulations, CEIV Pharma, WHO PQS, and other applicable industry standards.

· Provide technical leadership during customer audits and continuous improvement initiatives.

Qualifications:

· Bachelor’s degree in Engineering, Pharmaceutical Sciences, Logistics, or a related technical discipline.

· 5+ years of experience in pharmaceutical cold chain logistics, GDP compliance, or regulated quality systems.

· Demonstrated experience with CEIV Pharma certification requirements and audit processes.

· Knowledge of WHO PQS standards, particularly as they apply to cold chain equipment and procedures.

· Strong technical understanding of temperature mapping, validation protocols, and cold chain risk mitigation.

· Skilled in quality tools and methodologies: CAPA, RCA, 5 Whys, 8D, FMEA.

· Excellent written and verbal communication skills, with the ability to interface with internal teams, clients, and regulatory auditors.

Mandatory Fluent English and Italian Language, other language such as French, Spanish are a plus.

Preferred Qualifications:

· Certifications: GDP, ISO 9001 Lead Auditor, ASQ CQE, or CEIV Pharma-trained.

· Experience working with global health organizations, vaccines, or biologic product distribution.

· Familiarity with QMS platforms, data loggers, IoT-enabled temperature monitoring systems, and thermal packaging validation.

· Utilize: Microsoft Project, Smartsheet / Asana / Monday.com / Jira, Gantt Charts / RACI Matrices, Pareto Analysis, DMAIC

FedEx was built on a philosophy that puts people first, one we take seriously. We are an equal opportunity employer and we are committed to a diverse and inclusive workforce in which we provide growth opportunities for all

Our Company

FedEx is one of the world's largest express transportation companies and has consistently been selected as one of the top 10 World’s Most Admired Companies by "Fortune" magazine. Every day FedEx delivers for its customers with transportation and business solutions, serving more than 220 countries and territories around the globe. We can serve this global network due to our outstanding team of FedEx team members, who are tasked with making every FedEx experience outstanding.

Our Philosophy

The People-Service-Profit philosophy (P-S-P) describes the principles that govern every FedEx decision, policy or activity. FedEx takes care of our people; they, in turn, deliver the impeccable service demanded by our customers, who reward us with the profitability necessary to secure our future. The essential element in making the People-Service-Profit philosophy such a positive force for the company is where we close the circle, and return these profits back into the business, and invest back in our people. Our success in the industry is attributed to our people. Through our P-S-P philosophy, we have a work environment that encourages team members to be innovative in delivering the highest possible quality of service to our customers. We care for their well-being, and value their contributions to the company.

Our Culture

Our culture is important for many reasons, and we intentionally bring it to life through our behaviors, actions and activities in every part of the world. The FedEx culture and values have been a cornerstone of our success and growth since we began in the early 1970’s. While other companies can copy our systems, infrastructure and processes, our culture makes us unique and is often a differentiating factor as we compete and grow in today’s global marketplace.