Quality Systems Analyst II
Core
Ensure compliance and drive continual improvement for the Quality Management Systems across medical technology, defense, and industrial automation sectors.
Role type
Quality Systems Analyst
Builds
Quality management systems compliant with ISO 9001, ISO 13485, AS 9100, and Nadcap standards.
Domain
Manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Internal and external audit management, Corrective and Preventive Action (CAPA) coordination, regulatory guideline establishment, documentation management (DMRs, DHRs, complaint files), process validation support.
Preferred skills
Project management, knowledge of ISO 9001/13485/AS9100, regulatory standards familiarity.
Responsibilities
Lead and participate in internal and external audits (customer, regulatory, registrar); manage CAPA to ensure timely response and reporting; assist in establishing regulatory guidelines and industrial standards; support the design and installation of the quality system; communicate quality system requirements to internal customers.