Quality Engineer

Vor 3 Tagen


Zürich, Schweiz EPM Scientific - Phaidon International Vollzeit

My client is a leader in the medical device industry, dedicated to enhancing patient care with high-quality products and innovative technology.

Position Summary: We are seeking a skilled Quality Engineer to maintain quality management systems and drive continuous improvement in our manufacturing processes.

Key Responsibilities:

  1. Quality Management: Implement and maintain quality systems (ISO 13485, FDA, EU MDR).
  2. Process Improvement: Analyze and improve manufacturing processes to enhance quality.
  3. Validation: Conduct validation activities to ensure compliance.
  4. Risk Management: Perform risk assessments and implement mitigation strategies.
  5. Data Analysis: Analyze quality data and prepare reports.
  6. CAPA Management: Manage corrective and preventive actions.

Qualifications:

  1. Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
  2. 3-5 years of experience in quality engineering, preferably in medical devices.
  3. Knowledge of ISO 13485, FDA regulations, and EU MDR.
  4. Strong analytical, problem-solving, and communication skills.
  5. Proficiency in quality management tools.
  6. Fluent in English and German.
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