Hardware Quality Engineer at DentalMonitoring responsible for regulatory compliance and product documentation. Collaborating on new hardware product development and maintaining quality standards in a hybrid work environment.
Responsibilities
Ensure compliance with industrial standards and regulatory requirements
Create and improve hardware department procedures and work instructions within the framework of ISO 13485
Collaborate on in-house and subcontracted hardware development for new products
Coordinate cross-functional work performed by internal and external stakeholders/suppliers
Track project progress in terms of quality and timelines while ensuring expected performance targets are met
Contribute to the preparation of quality/regulatory documents 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
Monitor actions related to non-conformities
Participate in change integration
Requirements
Minimum 2 years of experience as a Hardware Quality Engineer / Hardware Engineer specialized in quality and compliance
Scientific education such as Master’s degree, PhD or engineering degree, or equivalent
Sense of confidentiality
Familiarity with industry standards and regulations
Rigorous, detail-oriented and strongly committed to quality
Comfortable with communication and able to collaborate smoothly in a (remote) team
Strong analytical and problem-solving skills
Fluent oral and written communication in French and English (minimum C1 in both languages)
Benefits
Swile meal card
Alan health insurance
Free share allocation plan (stock grants)
Hybrid work possible
Active works council (CSE) benefits (Urban Sports Club, club-employes.com)
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