QA Specialist
Core
Managing supplier quality compliance, leading corrective actions (CAPA), and overseeing supplier audits for medical device manufacturing.
Role type
Quality Assurance Specialist (Medical Devices)
Builds
Quality management systems and supplier compliance frameworks
Domain
Medical Devices / Quality Assurance
Required skills
Supplier audit execution, CAPA ownership and coordination, Root cause analysis, Quality system documentation, Statistical analysis, ISO 13485 knowledge
Preferred skills
Auditor certification, Medical device industry experience
Technologies
MS Office, E-Document management systems, Minitab
Responsibilities
Lead SCAR process including initiation, investigation, and closure; Conduct on-site and remote supplier audits; Manage CAPA lifecycle from problem statement to verification; Generate quality trending data for management reviews; Maintain Approved Supplier List and quality agreements.
Seniority
Mid-level, hands-on IC (via careerplan.io/jobs/C6-00F-FC-C66-qa-specialist)