Spontaneous Application
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Quality Affairs Specialist (Lead)
Education & Experience:
Bachelor's degree in Engineering, Life Sciences, Quality, or related field
Key Skills:
3+ years of hands-on quality experience in a medical device / medtech company
Experience in early-stage medtech start-ups or scaling quality systems from the ground up.
3+ years of hands-on quality experience in a medical device / medtech company
Cleanroom qualification and environmental monitoring experience.
Lead Auditor certification or internal auditor experience (ISO 13485).
Knowledge of IEC 62304, IEC 60601, ISO 10993, or usability standards.
Prior involvement in regulatory submissions or external audits.
Fully bilingual (English and French)