Quality Systems Specialist
Core
Ensure the quality, safety, and reliability of medical device products by managing change controls, investigations, audits, and product disposition.
Role type
Quality Systems Specialist (Medical Device)
Builds
Safe, compliant medical device products for patients and healthcare providers
Domain
Medical Device Manufacturing / Quality Assurance
Required skills
CAPA management, nonconformance investigations, change control, audit support, regulatory compliance (FDA 21 CFR 820/QMSR, ISO 13485), risk management, technical writing, data analysis
Preferred skills
Lead Auditor certification, multi-site experience, eQMS proficiency (TrackWise, Adobe), product release processes
Technologies
TrackWise, Adobe, ERP platforms
Responsibilities
Lead quality review and approval for change control records; Own and coordinate nonconformance investigations and CAPAs; Partner with cross-functional teams to resolve quality issues; Review manufacturing and release documentation for product disposition; Support internal, customer, and regulatory audits; Monitor quality system performance metrics and trends; Serve as subject matter expert for document control and procedural updates
Seniority
Mid-Senior level, hands-on IC