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Quality Assurance Engineer (m/f/d)

HHJ BAU GmbH · Urdorf

HHJ BAU GmbH seeks a Quality Assurance Engineer in Urdorf, CH, to manage quality workflows, risk analyses, and documentation for biotech projects. The role requires strong quality management experience and fluent English.

This position serves as the primary point of contact for quality matters within the project team, ensuring that all biotech development activities adhere to established standards and regulatory expectations.

Responsibilities

  • Handle Change Requests, Corrective and Preventive Actions (CAPAs), and Non-Conformities
  • Carry out defined workflows for biotech development initiatives
  • Perform risk and hazard analyses, including FMEA
  • Conduct incoming inspections, in-process controls, and FATs
  • Maintain and manage the electronic Document Management System (eDMS)
  • Support the implementation of a supplier management process

Requirements

  • Proven experience in Quality Management (Biotech, Pharma, or MedTech preferred)
  • Strong understanding of product development workflows
  • Familiar with standard quality processes and regulatory frameworks
  • Structured, detail-oriented, and proactive working style
  • Strong communication skills and ability to collaborate in cross-functional teams
  • Fluent in English

Nice to have

  • German language skills

What the company offers

  • A highly motivated team and an open way of communication
  • Valuable tips and feedback on application documents and interviews
  • Varied tasks in a renowned company

About the company

HHJ BAU GmbH provides engineering specialists with exciting projects and attractive job opportunities based on personal interests and experience. The company supports candidates throughout the entire process, from first contact to the first day on the new job.

  • The company provides engineering specialists with exciting projects and attractive job opportunities based on personal interests and experience.
  • The company supports candidates throughout the entire process, from first contact to the first day on the new job.

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