Quality Systems and Compliance Manager
Core
Develop, implement, and maintain the Quality Management System (QMS) for medical devices and industrial products, ensuring compliance with ISO 9001, ISO 13485, and EU MDR while leading risk management and supplier quality.
Role type
Senior IC Quality Systems and Compliance Manager
Builds
Medical devices and industrial monitoring systems for aerospace, defense, and environmental markets
Domain
Medical device manufacturing and industrial quality assurance
Required skills
ISO 9001:2015 expertise, ISO 13485:2016 expertise, EU MDR 2017/745 knowledge, ISO 14971 risk management, internal auditing, CAPA management, supplier quality management, regulatory compliance, data analysis, Lean principles
Preferred skills
Medical device industry experience, ISO 13485 lead auditor certification, ASQ CMQ/OE or CQE certification, Notified Body audit support experience, MDR technical documentation experience
Technologies
ISO 9001, ISO 13485, EU MDR, ISO 14971, FDA QSR
Responsibilities
Establish and maintain QMS processes; ensure regulatory compliance for medical devices; manage risk assessments and controls; oversee supplier qualification and audits; lead internal and external audits; manage nonconformance and CAPA processes; analyze customer complaints and post-market surveillance data; mentor quality personnel and develop departmental strategies
Seniority
Senior, hands-on IC with strategic leadership
