Senior Quality Engineer (m/f/d)


  • Develop and maintain quality system procedures to ensure compliance with regulations and standards (e.g. ISO 13485, FDA QSR)
  • Lead and participate in internal and external audits, ensuring that findings are appropriately addressed and documented
  • Work cross-functionally with R&D, Operations, and other departments to ensure that quality requirements are met throughout the product development lifecycle
  • Review and approve product documentation, including design control, risk management, and test protocols
  • Develop and implement process controls to ensure consistent product quality
  • Lead and participate in quality improvement initiatives, using statistical methods and tools to analyze data and identify root causes of issues
  • Provide guidance and leadership to the quality team, ensuring that they are trained and qualified to perform their roles effectively


  • Bachelor's degree in engineering or a related field
  • Minimum of 5 years of experience in the medical device industry, with a focus on quality engineering
  • Strong understanding of quality system regulations and standards (e.g. ISO 13485, FDA QSR)
  • Experience with product development processes, including design control and risk management
  • Strong analytical and problem-solving skills, with experience in statistical analysis and quality tools (e.g. SPC, DOE)
  • Excellent communication and interpersonal skills, with the ability to work effectively in a team environment
  • Certification in quality engineering (e.g. CQE, CRE) preferred
  • LEAN or Agile certification a strong asset

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Facts about the job

Contract type
permanent job
Coopers Group AG