Phadia GmbH
Laboratory Manager(m/w/x)
Full-timeOn-siteSenior
Freiburg im Breisgau
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THThermo Fisher Scientific Inc.
Head of Quality Control and Process Care(m/w/x)
Freiburg im Breisgau
Full-timeOn-siteManagement
Nejo AI Summary
Overseeing quality control testing for raw materials and finished goods, managing process care for IVD products. Leadership experience managing teams and ISO 13485/IVDR framework knowledge essential. Work impacting global health and safety.
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
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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ELISA
- ISO 13485
- IVDR
- SAP
- LIMS
Benefits
Retirement Plans
- Company pension scheme
Additional Allowances
- Fringe benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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THThermo Fisher Scientific Inc.
Head of Quality Control and Process Care(m/w/x)
Freiburg im Breisgau
Full-timeOn-siteManagement
Nejo AI Summary
Overseeing quality control testing for raw materials and finished goods, managing process care for IVD products. Leadership experience managing teams and ISO 13485/IVDR framework knowledge essential. Work impacting global health and safety.
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
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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ELISA
- ISO 13485
- IVDR
- SAP
- LIMS
Benefits
Retirement Plans
- Company pension scheme
Additional Allowances
- Fringe benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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.
Not a perfect match?
- Phadia GmbH
Laboratory Manager(m/w/x)
Full-timeOn-siteSeniorFreiburg im Breisgau - Thermo Fisher Scientific Inc.
Project Manager for Investment and Improvement Projects(m/w/x)
Full-timeOn-siteSeniorFreiburg im Breisgau - Phadia GmbH
Wissenschaftler:in / Design Responsible(m/w/x)
Full-timeOn-siteManagementFreiburg im Breisgau - providata GmbH
Leitung für unser Prozess- und Qualitätsmanagement(m/w/x)
Full-timeOn-siteSeniorSchwerin, Freiburg im Breisgau - Alcon
Head of Customer Operations DACH(m/w/x)
Full-timeOn-siteManagementFreiburg im Breisgau, Aschaffenburg