Hardware Quality Engineer ensuring compliance with industry standards at DentalMonitoring. Responsibilities include creating procedures, collaborating on product development, and maintaining quality documentation.
Responsibilities
Ensure compliance with industry standards and regulatory requirements
Create and improve hardware department procedures and work instructions within the ISO 13485 framework
Collaborate on hardware development of new products, internally or with subcontractors
Coordinate work carried out by different internal and external stakeholders and suppliers
Monitor project progress in terms of quality and timelines, ensuring expected performance is met
Contribute to the preparation of quality and regulatory documentation such as biological evaluations, technical files, and risk analyses; develop test plans; create and modify product labeling
Write quality control reports
Conduct internal and supplier audits
Track and follow up on actions related to non-conformities
Participate in the implementation of changes
Requirements
Minimum 2 years' experience in quality and compliance
Scientific education at Master's, PhD or Engineering degree level, or equivalent
Strong sense of confidentiality
Familiarity with industry standards and regulations
Rigour and attention to detail; commitment to quality
Analytical and problem-solving skills
Comfortable communicating orally and in writing in French and English (minimum C1 level in both languages)
Benefits
Swile lunch card
Alan health insurance
Free share allocation plan
Possible hybrid working arrangement
Active Works Council (CSE) benefits (Urban Sports Club, club-employes.com)
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