Healthcare Quality Engineer-Senior

Description

Acts as a technical expert on complex and specialist subject(s). Supports management with the analysis, interpretation and application of complex information, contributing to the achievement of divisional and corporate goals. Supports or leads projects by applying area of expertise.

"Please note that the Job will close at 12am on Posting Close date, so please submit your application prior to the Close Date"

What you’ll be working on:

• Support and maintain the Quality Management System (QMS) to meet GMP, GDP, CEIV Pharma, ISO 13485 and ISO 9001 standards for pharmaceutical transport and cold chain logistics
• Design, build, new, upgrade and repair existing pharmaceutical grade cold rooms, refrigeration units and refer vehicles to meet  stringent pharmaceutical storage and transport requirements as per regional and local standards.
• Lead temperature mapping and validation (DQ, PQ, OQ) of cold chain lanes, vehicles, packaging systems, aircrafts, refer containers, active containers and storage areas in alignment with WHO PQS (Performance, Quality and Safety) and regulatory expectations
• Analyze and respond to temperature excursions and deviations, by 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
• Interpret and apply WHO Performance, Quality and Safety (PQS) guidelines for equipment and process control in global health supply chains
• Conduct vendor and carrier qualification audits, including risk assessments, technical evaluations, and Quality Technical Agreement (QTA) development
• Design, and optimize processes for pharmaceutical clients, with a focus on temperature-sensitive products and regulatory compliance
• Manage vendors, price negotiation and contract signing with suppliers specifically for pharma grade refrigeration or medical-grade cooling systems.
• Conduct process mapping, time studies, and data analysis to identify inefficiencies and recommend improvements
• Oversee maintenance and general upkeep of the cold rooms in the region
• Collaborate cross-functionally to implement risk-based controls, corrective actions, and improvements to cold chain operations
• Collaborate with Quality, Operations, and IT teams to implement process improvements
• Generate and manage controlled documentation, including SOPs, work instructions, deviation reports, and training guides
• Deliver training and coaching to operations staff on cold room  handling, GDP requirements, and audit preparedness
• 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

You will be a good fit if you have:

Education: Bachelor's degree/equivalent in engineering or allied disciplines

Working Experience: Working Experience: Minimum of 3-4 year of relevant experience

• 3-4+ years of experience in designing & building pharmaceutical grade cold rooms
• Strong technical understanding of temperature mapping, validation protocols, and cold chain risk mitigation Experience cold chain logistics, GDP compliance, or regulated quality systems.
• Experience in vendor management and contract negotiation specifically for industrial refrigeration or medical-grade cooling systems.
• Strong understanding of O&M (Operations & Maintenance) best practices for large-scale cold storage facilities.
• Knowledge of WHO PQS standards, particularly as they apply to cold chain equipment and procedures.
• Demonstrated experience with CEIV Pharma certification requirements and audit processes.
• Skilled in root cause ana 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.
• 50% travel to countries around the region

Accuracy & Attention to Detail; Influencing & Persuasion Skills; Planning & Organizing; Problem Solving; Project Management Skills

FedEx was built on a philosophy that puts people first, one we take seriously. We are an equal opportunity/affirmative action employer and we are committed to a diverse, equitable, and inclusive workforce in which we enforce fair treatment, and provide growth opportunities for everyone.

All qualified applicants will receive consideration for employment regardless of age, race, color, national origin, genetics, religion, gender, marital status, pregnancy (including childbirth or a related medical condition), physical or mental disability, or any other characteristic protected by applicable laws, regulations, and ordinances.

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.