Innovation/Design Control & Project Quality Engineer

• Act as QA representative throughout the product lifecycle
• Perform operational quality activities from the design phase through completion of Design Transfer
• Provide Quality support to Design Control stakeholders
• Contribute to the implementation of Quality by Design (QbD) across R&D projects
• Participate in design risk assessment activities
• Be responsible for the Design History File (DHF) management process
• Support regulatory compliance and continuous improvement of the Design Control process
• Ensure proper application of related processes
• Participate in audits and inspections as a Subject Matter Expert (SME)

• University degree in Engineering or related field
• Minimum 7 years of professional experience in the Medical Devices or Pharmaceutical industry
• Minimum of 3 years in R&D Quality Assurance (Design)
• Strong knowledge of ISO 13485, IEC 62366, ISO 14971, and 21 CFR 820
• Knowledge of regulatory requirements applicable to medical devices
• Experience with audits and inspections against these standards is required
• Knowledge of Quality by Design (QbD)
• Fluent in English

French is an asset