Business Systems Analyst position responsible for implementing system and process improvements in Document Control at a medical device company. The role involves managing change orders, collaborating across departments, and ensuring regulatory compliance with PLM systems and document control standards.
Responsibilities
Execute PLM system and document control process improvements using Agile methodologies
Process change orders accurately and audit documentation for compliance with regulatory requirements
Represent Document Control in project requirements definition and participate in cross-functional project teams
Create test scripts, execute user acceptance testing, and coordinate with CSV groups on regulatory compliance
Update procedures, resolve complex tickets, and provide clear communication to internal stakeholders
Requirements
6-10 years work experience in regulatory or quality organizations in medical device companies
Knowledge of PLM systems (Agile preferred) including functional and technical aspects
Understanding of change control principles for document control and IT systems
Experience with cross-functional project teams and process improvement initiatives
Proficiency in Microsoft Office products (Word, Excel, Visio)
Strong analytical thinking, problem-solving, and attention to detail
University degree; Quality Systems Regulations, ISO, Project Management, and Validation training
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