Software Quality Specialist (fixed-term contract) - Spécialiste Qualité Logicielle CDD (H/F)
Core
Ensuring quality and regulatory compliance for medical device products and processes across design, manufacturing, and service.
Role type
Quality Management System (QMS) Specialist
Builds
Compliance activities, quality metrics, and operational mechanisms for medical devices
Domain
Medical Devices / Regulated Industry
Deliverable
client delivery
Required skills
QMS system management, regulatory compliance, process improvement, root cause analysis, technical documentation review, MS Office proficiency
Preferred skills
FDA CFR 21 Part 820 knowledge, ISO 13485 knowledge, Software as a Medical Device (SaMD) experience, design controls expertise, risk management expertise
Technologies
MS Office (Word, Excel, PowerPoint), databases
Responsibilities
Drive compliance activities for specific products/sites/regions; Represent company to external agencies; Collaborate with design, manufacturing, and service teams; Solve problems using technical expertise and analytical thinking; Provide guidance to team members on complex QMS topics
Seniority
Individual Contributor, mid-level