Quality Manager (LMR) (m/w/d)
Core
Local Management Representative for a medical device manufacturing site, responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) and quality processes to ensure regulatory compliance and patient safety.
Role type
Senior Quality Manager (Medical Device Manufacturing)
Builds
Medical device manufacturing operations compliant with ISO 13485, EU-MDR, and FDA regulations
Domain
Healthcare / Medical Devices / Manufacturing
Required skills
Quality Management System (QMS) management, Regulatory compliance (EU-MDR, FDA), CAPA management, Risk management, Team leadership, Strategic planning, Process validation, Stakeholder management, German, English
Preferred skills
Experience as Quality Management Representative (QMB), ISO 13485 certified environment experience, Non-active medical devices manufacturing experience
Technologies
ISO 13485, EU-MDR, FDA regulations, CAPA, Change Control, Non-conformance management
Responsibilities
Ensure QMS effectiveness and regulatory compliance, Define and monitor quality performance via KPIs, Act as primary contact for management, customers, and regulators, Lead the Quality Team, Manage CAPA and corrective/preventive actions, Prepare for external audits and inspections, Escalate quality risks, Collaborate with operational areas to meet quality standards.
Seniority
Senior, hands-on IC with leadership responsibilities