Senior Quality Systems Specialist - Integration
Core
Leading and executing quality system integration activities to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and global medical device regulations.
Role type
Senior Quality Systems Specialist (Integration)
Builds
Harmonized, compliant quality management systems for medical device organizations
Domain
Medical Devices / Regulatory Quality Systems
Required skills
Gap assessment, process mapping, regulatory compliance (FDA/ISO), procedure harmonization, cross-functional partnership, risk identification, audit support, technical writing
Preferred skills
Manufacturing environment experience, regulated environment interaction, Level 6 qualification
Technologies
MS Project, Adobe Acrobat, Electronic Document Management Systems
Responsibilities
Assess and document current-state quality system processes; Perform process mapping and gap assessments; Develop and harmonize procedures and documentation; Partner with process owners to determine disposition of existing processes; Identify compliance risks and business impacts; Support verification of QMS changes; Facilitate document review and issuance; Collaborate on training implementation; Support integration-related internal and external audits
Seniority
Senior, hands-on IC