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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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- 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
Attraktive Vergütung
- Attractive compensation package
Sonstige Zulagen
- Tuition Assistance Program
Flexibles Arbeiten
- Hybrid working policy
Mentale Gesundheitsförderung
- Employee Assistance Program
Mitarbeiterrabatte
- Employee reduced-rate shipping
Karriere- und Weiterentwicklung
- 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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- 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
Attraktive Vergütung
- Attractive compensation package
Sonstige Zulagen
- Tuition Assistance Program
Flexibles Arbeiten
- Hybrid working policy
Mentale Gesundheitsförderung
- Employee Assistance Program
Mitarbeiterrabatte
- Employee reduced-rate shipping
Karriere- und Weiterentwicklung
- Growth opportunities
Über das Unternehmen
DEG FedEx Express Deutschland GmbH
Branche
Transportation
Beschreibung
FedEx Express is one of the world's largest express transportation companies, delivering solutions in over 220 countries.
Noch nicht perfekt?
- DEG FedEx Express Deutschland GmbH
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