Beschreibung

In this role, you will bridge the gap between research and quality assurance, ensuring that innovative developments meet regulatory standards. Your day-to-day responsibilities will include enhancing the quality management system, conducting audits, and leading risk management efforts.

Anforderungen

• •Degree in engineering, medical technology, computer science, natural sciences, or comparable field
• •4+ years of professional experience as a Quality Engineer
• •Deep familiarity in QMS frameworks (ISO 13485 and/or GMP)
• •Proven expertise in risk management (ISO 14971, ISO 12100)
• •Practical application of hazard evaluation methods (FTA, FMEA, Ishikawa, HAZOP)
• •Experience with CAPA tools (8D reports)
• •Knowledge of the approval process for machines and systems for the US market
• •Well structured, hands-on approach with strong analytical skills
• •Fluency in English with strong written and verbal communication skills
• •Comfortable working in an international and cross-functional team

Aufgaben

• •Act as the main liaison between R&D and QA divisions
• •Establish and improve the QMS framework in R&D
• •Ensure compliance of Clinical Polarizer development with QMS standards
• •Administer the QMS tool and manage the internal standards database
• •Analyze product defects and initiate corrective actions
• •Plan and deliver internal training on quality topics
• •Execute internal and external audits and assist with supplier monitoring
• •Lead the risk management process for the Polarizer development
• •Support Preclinical Polarizer development with QA expertise

Benefits