Job Summary: Quality Engineer with experience in injection molding and ISO 13485 Quality Management Systems to develop and improve procedures. Key Highlights: 1. Implementation and continuous improvement of the ISO 13485 Quality Management System 2. Development of quality documentation and procedures 3. Experience in injection molding and mold validation Description and details of responsibilities Support the implementation, maintenance, and continuous improvement of the ISO 13485 Quality Management System. Develop, document, and revise quality procedures, create work instructions, and policies to align with ISO standards. Establish and maintain detailed quality documentation, including control plans, process flow diagrams, PFMEA, and inspection plans. ISO Lead Auditor Certification. Ability to support inspection of first articles, in-process parts, and products prior to shipment using gauges, coordinate measuring machine, optical comparators, and vision. Ability to perform measurements and data collection in support of SPC activities and product validations. Experience and requirements 3+ years of experience as a Quality Engineer in an injection molding environment Experience in molding process, mold validation and direct participation in molded part transfer projects. Support the implementation, maintenance, and continuous improvement of the ISO 13485 Quality Management System. Benefits * Benefits according to the Federal Labor Law (LFT) Apply for this position directly through our portal APPLY **Number of vacancies** 1 **Department** Quality **Contract type** Permanent **Work modality** On-site **Shift** Day shift **Working hours** Full-time **Schedule*** Full-time * Monday to Friday **Education** Bachelor's degree **English** Spoken: Advanced, Written: Advanced **Willingness to travel** No