Staff Quality Management Systems Specialist (Onsite)
Core
Administer and continuously improve document and change control processes within a regulated medical device environment.
Role type
Staff Quality Management Systems Specialist
Builds
Controlled documentation, quality records, and change activities
Domain
Medical device industry + Quality Management Systems
Required skills
Document control, Change control, Quality Management Systems compliance, Good Documentation Practices (GDP), Procedure development, Record management, Cross-functional collaboration, Team mentoring
Preferred skills
Medical device industry experience, Regulated industry experience, Science/Engineering degree
Technologies
Microsoft Office 365
Responsibilities
Coordinate document and change control activities, Review quality records for compliance, Track documentation reviews and approvals, Verify completion of change-control activities, Maintain controlled documents and records, Collaborate to create and revise procedures, Guide Document Control team members
Seniority
Staff, hands-on IC