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Thermo Fisher Scientific Inc.
5d ago

Head of Quality Control and Process Care(m/w/x)

Freiburg im Breisgau
Full-timeOn-siteManagement

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.

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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

Bachelor's degree

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

ELISAISO 13485IVDRSAPLIMS

Languages

GermanBusiness Fluent

EnglishBusiness Fluent

Benefits

Retirement Plans

  • Company pension scheme

Additional Allowances

  • Fringe benefits
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