Quality System Manager
Core
Developing, implementing, and maintaining Quality Management Systems (QMS) to ensure compliance with standards like ISO 9001:2015 and 21 CFR Part 820 for medical devices.
Role type
Quality System Manager
Builds
Quality Management Systems (QMS) and documentation frameworks
Domain
Medical Devices / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS development and implementation, audit management, CAPA administration, document control, regulatory compliance (ISO 9001:2015, 21 CFR Part 820), change management, validation oversight, process standardization, project management
Preferred skills
Enterprise IT systems experience (ERP, SAP, CRM, Agile, SharePoint), mentorship of process owners
Technologies
SAP, CRM, Agile, SharePoint, PLM, MRP
Responsibilities
Develop and implement quality management processes and procedures; Organize, lead, and coordinate internal quality audits; Administer and manage the CAPA and NC system; Create and maintain QMS documentation including procedures and work instructions; Act as liaison for OEM document centers processing change requests and deviations; Execute test scripts and write test reports for validation/verification; Support internal, external audits, and facility inspections; Provide QMS support and training for the business unit
Seniority
Senior, hands-on IC