Senior Quality Engineer (m/f/d)

Responsibilities:

• 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

Qualifications:

• 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