Quality Manager (m/w/d)
Core
Ensuring quality management system compliance for medical devices across the product lifecycle, from design to post-market surveillance. (via careerplan.io/jobs/2780059-quality-manager-mwd)
Role type
Quality Manager (Medical Devices)
Builds
Medical device products compliant with EU MDR, FDA 21 CFR, and ISO 13485 standards.
Domain
Medical Technology / Regulatory Compliance
Required skills
Quality Management Systems (QMS) management, SOP development, audit coordination (internal and supplier), complaint handling, non-conforming product management, corrective and preventive actions (CAPA), post-market surveillance (PMS), supplier qualification, marketing content review, ERP/DMS/LMS system usage.
Preferred skills
Medical device industry experience, hands-on operational mindset, advanced MS Office skills.
Responsibilities
Update and monitor QMS documentation per MDR, ISO 13485, and FDA requirements; develop and implement SOPs; prepare for and accompany regulatory inspections and certification audits; coordinate supplier qualifications and audits; conduct internal audits; manage complaint processing and CAPA; analyze quality data for post-market surveillance; approve end products and marketing materials.
Seniority
Mid-level, hands-on IC