Beschreibung

As a Quality Engineer in the medical devices sector, you will play a crucial role in ensuring product quality by developing standards, collaborating with engineering teams, and conducting thorough analyses. Your expertise will be vital in maintaining compliance and supporting continuous improvement efforts.

Anforderungen

• •Bachelor's degree in engineering discipline
• •Practical knowledge of global regulations and standards for medical devices
• •At least 3 years of experience in medical device industry or similar regulated environment
• •Fluent in German and English
• •Good analytical skills
• •Process-oriented and high level of accuracy
• •Ability to work in multidisciplinary and international team
• •Knowledge of standard MS Office, especially Word
• •Knowledge of DOE and statistical software Minitab

Aufgaben

• •Support quality development activities for commercial production
• •Ensure compliance with quality system requirements and standards
• •Collaborate with Manufacturing Engineering on FMEAs and risk management documents
• •Assist in the validation and re-validation of test methods and processes
• •Develop, review, and approve protocols and reports for test method validation
• •Support the Manufacturing Engineering team with quality-related tasks
• •Conduct statistical analyses to determine process capability indicators
• •Assist in implementing process qualification and validation activities
• •Support corrective and preventive actions, including root cause analyses
• •Act as a quality expert during regulatory audits

Tools & Technologien