Engineer in Qualification, Computerized System Validation (CSV), and Continuous Improvement

I am a trilingual Biomedical Engineer (French/English/Arabic) with dual academic training from UTC Compiègne (France) and ENSAM Rabat (Morocco), and over one year of experience. I specialize in qualification and validation, medical device compliance, and continuous process optimization. I offer freelance services including: - Equipment qualification and validation (IQ, OQ, PQ) in the medical device and pharmaceutical industries - Continuous improvement and lean-based process optimization (DMAIC methodology) - Regulatory compliance with ISO 13485, MDR 2017/745, 21 CFR Part 11, and GAMP 5 - Maintenance strategy development and medical equipment lifecycle management - Support in drafting technical documentation and preparation for audits in medtech and pharma sectors My background combines hands-on technical experience in hospital and manufacturing environments with strong knowledge of quality assurance systems. I help clients ensure regulatory compliance, streamline operations, and bring safer, high-quality healthcare products to market.