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Senior Healthcare Quality Engineer(m/w/x)
Quality assurance for pharmaceutical cold chain logistics, validating transport lanes and storage areas. Experience in pharmaceutical cold chain and CEIV Pharma certification required. Tuition assistance, employee reduced-rate shipping.
Requirements
- Degree in Engineering, Pharmaceutical Sciences, or Logistics
- Experience in pharmaceutical cold chain or GDP
- Experience with CEIV Pharma certification and audits
- Knowledge of WHO PQS standards
- Technical understanding of temperature mapping and validation
- Skill in quality tools like CAPA/FMEA
- Excellent written and verbal communication skills
- Fluent English and German language skills
- GDP, ISO 9001, or ASQ certifications
- Experience with global health or biologics
- Familiarity with QMS and IoT monitoring
- Proficiency in project management and analysis tools
Tasks
- Maintain the QMS for pharmaceutical transport
- Validate cold chain lanes and storage areas
- Analyze temperature excursions and deviations
- Implement root cause analysis and CAPAs
- Prepare validation protocols and mapping records
- Manage CEIV Pharma and IATA compliance audits
- Conduct vendor and carrier qualification audits
- Apply WHO PQS guidelines to supply chains
- Implement risk-based controls for cold chain operations
- Generate SOPs and controlled documentation
- Train staff on temperature-sensitive handling
- Optimize processes for pharmaceutical clients
- Perform process mapping and time studies
- Support customer onboarding and RFQ responses
- Define KPIs and develop operational SOPs
- Lead technical initiatives during customer audits
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- CAPA
- RCA
- 5 Whys
- 8D
- FMEA
- QMS platforms
- Data loggers
- IoT-enabled temperature monitoring systems
- Thermal packaging validation
- Microsoft Project
- Smartsheet
- Asana
- Monday.com
- Jira
- Gantt Charts
- RACI Matrices
- Pareto Analysis
- DMAIC
Benefits
Competitive Pay
- Attractive compensation package
Additional Allowances
- Tuition Assistance Program
Flexible Working
- Hybrid working policy
Mental Health Support
- Employee Assistance Program
Corporate Discounts
- Employee reduced-rate shipping
Career Advancement
- Growth opportunities
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Senior Healthcare Quality Engineer(m/w/x)
Quality assurance for pharmaceutical cold chain logistics, validating transport lanes and storage areas. Experience in pharmaceutical cold chain and CEIV Pharma certification required. Tuition assistance, employee reduced-rate shipping.
Requirements
- Degree in Engineering, Pharmaceutical Sciences, or Logistics
- Experience in pharmaceutical cold chain or GDP
- Experience with CEIV Pharma certification and audits
- Knowledge of WHO PQS standards
- Technical understanding of temperature mapping and validation
- Skill in quality tools like CAPA/FMEA
- Excellent written and verbal communication skills
- Fluent English and German language skills
- GDP, ISO 9001, or ASQ certifications
- Experience with global health or biologics
- Familiarity with QMS and IoT monitoring
- Proficiency in project management and analysis tools
Tasks
- Maintain the QMS for pharmaceutical transport
- Validate cold chain lanes and storage areas
- Analyze temperature excursions and deviations
- Implement root cause analysis and CAPAs
- Prepare validation protocols and mapping records
- Manage CEIV Pharma and IATA compliance audits
- Conduct vendor and carrier qualification audits
- Apply WHO PQS guidelines to supply chains
- Implement risk-based controls for cold chain operations
- Generate SOPs and controlled documentation
- Train staff on temperature-sensitive handling
- Optimize processes for pharmaceutical clients
- Perform process mapping and time studies
- Support customer onboarding and RFQ responses
- Define KPIs and develop operational SOPs
- Lead technical initiatives during customer audits
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- CAPA
- RCA
- 5 Whys
- 8D
- FMEA
- QMS platforms
- Data loggers
- IoT-enabled temperature monitoring systems
- Thermal packaging validation
- Microsoft Project
- Smartsheet
- Asana
- Monday.com
- Jira
- Gantt Charts
- RACI Matrices
- Pareto Analysis
- DMAIC
Benefits
Competitive Pay
- Attractive compensation package
Additional Allowances
- Tuition Assistance Program
Flexible Working
- Hybrid working policy
Mental Health Support
- Employee Assistance Program
Corporate Discounts
- Employee reduced-rate shipping
Career Advancement
- Growth opportunities
About the Company
DEG FedEx Express Deutschland GmbH
Industry
Transportation
Description
FedEx Express is one of the world's largest express transportation companies, delivering solutions in over 220 countries.
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