Senior Quality Assurance Specialist
Core
Managing document control, change control, supplier quality assurance, and audit support within a regulated manufacturing environment.
Role type
Senior Quality Assurance Specialist (Document & Change Control)
Builds
Compliant documentation, change records, supplier quality resolutions, and audit readiness
Domain
MedTech/Pharma manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAP DMS, Document Management Systems, ISO 13485, 21 CFR 820, ECO tracking, SCAR management, MS Word/Excel, regulatory compliance
Preferred skills
ERP experience, MedTech/Pharma industry background
Technologies
SAP, MS Office
Responsibilities
Ensure documents are created and maintained according to QMS procedures; Verify Change Requests prior to approval and link BOMs/routers/inspection sheets into SAP; Issue quality notifications and SCARs to suppliers; Support internal and external audits (QMS and MAPPS)
Seniority
Senior, hands-on IC