Quality Engineer - Pharma Logistics & Cold Chain
Description
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.
Essential Functions
- 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
Additional Job Information
- 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.
Minimum Education
Bachelor’s degree/equivalent in Engineering, Business, Transportation or related discipline.
Minimum Experience
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.
Knowledge, Skills and Abilities
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
Job Conditions
None.
Preferred Qualifications: 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/Monday.com/Jira, Gantt Charts, RACI Matrices, Pareto Analysis, and DMAIC.
Pay Transparency:
Pay: Ontario, CA Pay Range: $6,854.33/month - $11,309.65/month (E25)
Additional Details: This position will be hybrid in Ontario, CA and candidates must live within a 50 mile radius. Employees will be required to work at a FedEx office location up to several times per week.
Pay Transparency:
The compensation listed reflects the pay range or rate of pay reasonably expected for this posted position at the posted location or locations. If this opportunity includes multiple job levels, the pay information represents the minimum and maximum range for all levels in that job family. Actual pay is determined by several job-related factors permitted by law and relevant to the position, including, but not limited to, experience relative to the job, tenure, market level, pay at the location for this job, performance, schedule, and work assignment.
LA County: Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the City of Los Angeles Fair Chance Initiative for Hiring Ordinance, and the California Fair Chance Act.
FedEx complies with criminal history and Security Threat Assessment (STA) screening requirements defined by the Transportation Security Administration (TSA) for positions requiring security identification display area (SIDA) access, Department of Transportation (DOT) Federal Motor Carrier Safety Administration (FMCSA) regulations for commercial driving positions, Department of Defense Facility Security Office standard procedures in covered facilities, and all other laws, regulations, or executive orders, including those required by federal, state, or local government contract, or which the Attorney General determines to be essential for an employer to do business with an agency or department of the federal, state, or local government.
Federal Express Corporation is an Equal Opportunity Employer including, Vets/Disability.
Reasonable accommodations are available for qualified individuals with disabilities throughout the application process. Applicants who require reasonable accommodations in the application or hiring process should contact recruitmentsupport@fedex.com.
Applicants have rights under Federal Employment Laws:
- Know Your Rights
- Pay Transparency
- Family and Medical Leave Act (FMLA)
- Employee Polygraph Protection Act
E-Verify Program Participant: Federal Express Corporation participates in the Department of Homeland Security U.S. Citizenship and Immigration Services’ E-Verify program (For U.S. applicants and employees only). Please click below to learn more about the E-Verify program:
