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The following responsibilities await you:

• Champion risk management during new developments, partnering with product teams.
• Spearhead risk management initiatives throughout the medical device lifecycle.
• Oversee QMS updates pertinent to risk management.
• Champion in NCR and CAPA initiatives.
• Impart risk management training expertise.
• Vigilantly maintain the Risk Management File.
• Offer relentless support for both internal and external audits.

What we expect from you:
• Education: Bachelor’s/Master’s in an engineering/science domain or its equivalent.
• Experience: 5+ years honing expertise in risk management within the realm of medical devices or pharmaceuticals.
• Knowledge: Fluent with standards like ISO14971, ISO13485, FDA Quality System Regulations, IEC 62304, and GMPs.
• Adeptness in orchestrating cross-functional risk management dialogues.
• Robust problem-solving prowess, with a keen focus on NCR/CAPA processes.
• Commanding communication skills in English and French.

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