Are you passionate about technology and like to take on complex technical challenges? Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?

• Prepares, executes, and finalizes protocols (IQ, OQ, PQ, PVP and PVR) for validating current, new and improved manufacturing processes.
• Establish and review protocols, reports, procedures, specifications and systems to provide QSR / ISO compliance consistent with the development of medical device products.
• Conduct and lead process/design failure mode effects and analysis.
• Represents the company as the point of contact with regulatory agencies, including interface with the FDA inspectors.
• Behave as a leader in all areas of the Quality Systeam.

• Bachelor degree in an engineering or equivalent field.A Masters degree is a plus.
• At least 3 years of related experiencein a medical device or a healthcare discipline is required.
• Strong experience in designing verification/validation, process verification/validation, and design/process failure modes and effects analyses.
• Working experience with PQR is a big plus.
• Knowledge of Good Manufacturing Practices (GMP).
• Knowledge and application of FDA QSR, ISO 13485:2003, and ISO 14971:2007 is preferred
• Proficiency with the Microsoft Office Suite.
• Fluent in English and French.

We are looking forward to getting to know you and your ambitions!