Quality Assurance Engineer
Core
Support process owners in defining and implementing process and system changes to improve efficiency and strengthen the local quality management system across Engineering, Order Fulfilment, Regulatory Affairs, Sales, Marketing, and Manufacturing.
Role type
Quality Assurance Engineer
Builds
Quality management systems and compliant operational workflows
Domain
Medical device manufacturing and regulatory compliance
Deliverable
dashboards & analysis
Required skills
Regulatory knowledge (ISO 13485, ISO 14971, MDD, MDR, FDA), audit planning and execution, non-conformance management, process improvement, technical quality support, document control
Preferred skills
Lean, Six Sigma, design of experiments, statistical methods, quality certification
Technologies
ISO 13485, ISO 14971, ISO 14001, IEC standards, MDD, MDR, US FDA quality system requirements
Responsibilities
Contribute to projects ensuring activities meet quality and regulatory requirements; Prepare and analyze monthly quality metrics; Represent the organization in corrective and preventive action processes; Provide technical quality support to colleagues; Participate in external audits and support internal audit plans; Issue non-conformities and support closure; Support process and procedure changes including document authorization; Promote continuous improvement and adherence to company values.
Seniority
Mid-level, hands-on IC