Quality Assurance Specialist

DentalMonitoring

. Maintain and improve the quality management system in accordance with ISO 13485, the MDR, 21 CFR, and MDSAP requirements .

Posted 10/16/2026full-timeParis • FranceJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in maintaining quality management systems in compliance with ISO 13485, MDR, and 21 CFR standards, while fostering a quality culture and ensuring effective collaboration across product teams. Proficient in analyzing KPIs and managing nonconformities within the medical device industry.

Highest-signal resume keywords

ISO 13485 ComplianceQuality Management System MaintenanceMedical Device Quality AssuranceFluent in English and FrenchInternal and External Audits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceKPI AnalysisNonconformity ManagementChange ControlPost-Market Surveillance

Soft Skills

Effective CommunicationAdaptabilityAttention to DetailInitiativeRelationship Building

Industry Keywords

MDR21 CFRMDSAPBiomedical EngineeringBiotechnology

About the role

Key responsibilities & impact

Maintain and improve the quality management system in accordance with ISO 13485, the MDR, 21 CFR, and MDSAP requirements
Collaborate with product teams to ensure compliance and traceability across the company
Contribute to developing a quality culture and raise employees’ awareness of quality assurance
Actively participate in internal and external audits
Manage nonconformities and change control
Analyze KPIs and ensure process performance
Contribute to post-market surveillance activities
Collaborate with R&D, Clinical, and Marketing teams

Requirements

What you’ll need

At least 1 year of experience as a QARA Specialist
Engineering degree or Master’s degree in biomedical engineering or biotechnology
Fluent in English and French, with a minimum C1 level in both languages
Adaptability and a strong willingness to learn
Ability to work in a scale-up/start-up environment
Versatility and the ability to take initiative
Effective communication skills and the ability to build relationships with internal and external stakeholders
Excellent organizational and analytical skills
Highly rigorous, with strong attention to detail
Previous successful experience or specialization in medical device quality assurance is a plus

Benefits

Comp & perks

Swile meal benefits card
Alan health insurance
Free stock option plan
Hybrid working arrangement (2 days per week remotely)
Works Council benefits (multi-activity sports pass, club-employes.com)
Company events
Employee referral program
Inclusive and multicultural work environment
Reasonable accommodations for people with disabilities