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The Quality Engineer plays a key role in evaluating and maintaining product and service quality. They collaborate cross-functionally to address equipment and process-related production issues, ensuring compliance with FDA/ISO requirements and industry standards.
Job Responsibility:
Evaluate and maintain product and service quality
Resolve equipment and process-related production issues
Conduct equipment, process, materials, and method validation
Perform statistical analysis and metrics to assess systems and processes
Develop and execute test protocols, collect data, and write validation reports
Collaborate cross-functionally in product/service development or maintenance
Requirements:
Minimum 2 years of applicable experience in a related role
Experience with GMP in medical devices and/or pharmaceuticals is a must
Supplier quality experience is a plus
Bachelor’s degree (BS) or equivalent required
Basic knowledge of theories, practices, and procedures in quality engineering
Ability to work under direct supervision and perform routine tasks
Basic knowledge of quality engineering policies, principles, and best practices
Basic statistical sampling and analysis skills
Competence in writing test protocols and validation reports