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Head of Quality Control and Process Care(m/w/x)
Description
You will lead the company's quality control and process care teams, ensuring technical excellence and compliant operations while driving continuous improvement across the entire product lifecycle.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Degree in natural, medical sciences, engineering, or equivalent
- •Experience in diagnostics, immunoassays, ELISA, or IVD products
- •Experience in Quality Control in regulated environments
- •Leadership experience managing team leaders and teams
- •Experience with ISO 13485 and IVDR frameworks
- •Understanding of QC testing and goods release
- •Knowledge of OOS, CAPA, and change control
- •Knowledge of validation principles and method lifecycle
- •Experience with audits and inspections
- •Fluent German and English skills
- •Strong IT skills, SAP and LIMS preferred
- •Decision-making skills in regulated environments
- •Ability to balance efficiency and compliance
- •Business acumen and budget management experience
- •Structured, risk-based problem-solving approach
- •Stakeholder management and communication skills
- •Experience in matrix and international organizations
- •Change leadership and continuous improvement mindset
Education
Work Experience
approx. 4 - 6 years
Tasks
- •Lead quality control testing for raw materials and finished goods
- •Improve analytical and immunological test methods
- •Ensure routine testing readiness and data integrity
- •Manage process care activities throughout the product lifecycle
- •Oversee process validation and method lifecycle management
- •Collaborate with R&D on product care and design transfers
- •Approve quality-relevant validation within production interfaces
- •Represent quality control in engineering and R&D projects
- •Define routine testing and execute validation protocols
- •Act as the technical interface for manufacturing and QA
- •Support investigations using data-driven root cause analysis
- •Lead and develop quality control and process care teams
- •Manage cost center budgets and resource planning
- •Drive continuous improvement in quality and compliance
- •Support operational excellence and process scalability
Tools & Technologies
Languages
German – Business Fluent
English – Business Fluent
Benefits
Retirement Plans
- •Company pension scheme
Additional Allowances
- •Fringe benefits
- Phadia GmbHFull-timeOn-siteSeniorFreiburg im Breisgau
- Thermo Fisher Scientific Inc.
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Head of Quality Control and Process Care(m/w/x)
The AI Job Search Engine
Description
You will lead the company's quality control and process care teams, ensuring technical excellence and compliant operations while driving continuous improvement across the entire product lifecycle.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Degree in natural, medical sciences, engineering, or equivalent
- •Experience in diagnostics, immunoassays, ELISA, or IVD products
- •Experience in Quality Control in regulated environments
- •Leadership experience managing team leaders and teams
- •Experience with ISO 13485 and IVDR frameworks
- •Understanding of QC testing and goods release
- •Knowledge of OOS, CAPA, and change control
- •Knowledge of validation principles and method lifecycle
- •Experience with audits and inspections
- •Fluent German and English skills
- •Strong IT skills, SAP and LIMS preferred
- •Decision-making skills in regulated environments
- •Ability to balance efficiency and compliance
- •Business acumen and budget management experience
- •Structured, risk-based problem-solving approach
- •Stakeholder management and communication skills
- •Experience in matrix and international organizations
- •Change leadership and continuous improvement mindset
Education
Work Experience
approx. 4 - 6 years
Tasks
- •Lead quality control testing for raw materials and finished goods
- •Improve analytical and immunological test methods
- •Ensure routine testing readiness and data integrity
- •Manage process care activities throughout the product lifecycle
- •Oversee process validation and method lifecycle management
- •Collaborate with R&D on product care and design transfers
- •Approve quality-relevant validation within production interfaces
- •Represent quality control in engineering and R&D projects
- •Define routine testing and execute validation protocols
- •Act as the technical interface for manufacturing and QA
- •Support investigations using data-driven root cause analysis
- •Lead and develop quality control and process care teams
- •Manage cost center budgets and resource planning
- •Drive continuous improvement in quality and compliance
- •Support operational excellence and process scalability
Tools & Technologies
Languages
German – Business Fluent
English – Business Fluent
Benefits
Retirement Plans
- •Company pension scheme
Additional Allowances
- •Fringe benefits
About the Company
Thermo Fisher Scientific Inc.
Industry
Science
Description
The company is a world leader in serving science, enabling customers to make the world healthier, cleaner, and safer.
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Full-timeOn-siteManagementFreiburg im Breisgau, Aschaffenburg