Job Responsibilities:
Lead the change control process for product changes, process changes, and documentation changes throughout their lifecycle.
Evaluate change requests for completeness, accuracy, and compliance with regulatory requirements (e.g., US FDA, CE, ISO).
Collaborate with cross-functional teams including Research & Development, Regulatory Affairs, Quality Assurance, Manufacturing, and Supply Chain to assess the impact of proposed changes.
Facilitate change review meetings and ensure timely resolution of issues and decisions.
Develop and maintain change control procedures, templates, and forms.
Ensure that changes are properly documented, including rationale, risk assessment, validation requirements, and verification activities.
Provide guidance and training to employees on change control procedures and best practices.
Lead and manage multiple projects concurrently throughout their lifecycle from initiation to closure.
Develop and execute validation protocols and reports for equipment, processes, and systems used in the manufacture and testing of medical devices including sterilization.
Conduct qualification studies for equipment and software, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Ensure that validation activities are conducted in accordance with FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other applicable regulatory requirements.
Develop and maintain validation master plans, protocols, and validation summaries.
Analyse validation data, prepare summary reports, and make recommendations for process improvements.