Required Configuration Control Admin
The position summary:
Configuration Control Admin is responsible for managing and overseeing the change management process in the Product Lifecycle Management (PLM) system within the organization and maintaining the ongoing efficiency of this system, which includes, identifying and documenting standard work, creating training tools, and providing training for colleagues. This position will create, define, and analyze business reports, track key performance indicators (KPIs), and collaborate with colleagues to ensure the smooth operation of our product lifecycle management processes. Ensuring applicable regulatory and Quality Management System (QMS) standards are met.
What you will be doing:
Change Management-
Generate and manage Engineering Change Orders (ECO) till implementation, ensuring accurate and complete documentation for all parts, materials, and assemblies in adherence to change control policies and design drafting standards.
Facilitate Change Control Board (CCB) meetings and relevant change management cross-functional and cross-platform activities.
Provide and document existing and new users' training on the ECO process.
Provide ongoing support and guidance to users to ensure proper system usage.
Develop and maintain documentation, including configuration management plans, policies, and procedures, to establish a structured framework for configuration control.
Regulatory Compliance-
Ensure that all configuration management processes, and documentation comply with relevant regulatory requirements and standards, such as ISO 13485, FDA regulations, MDR, MDSAP, and other medical device regulations.
Assist in implementing robust change control processes to ensure that any changes to medical device configurations are properly assessed, authorized, and documented. Changes must be validated and verified before implementation.
Continuous improvement-
Lead and support continuous improvement activities to reduce variation and waste to acceptable targets
Identify develop, and document standard work procedures related to configuration control, change control process, and product lifecycle management
Create and manage business reports to track product and process data, identify trends for optimization, and monitor KPIs related to configuration control and change management.
Requirements: Must have for this role:
5+ years of experience in engineering change management
3+ years of experience with Agile Product Lifecycle Management (PLM) software
Leadership skills
Strong analytical, problem-solving, and decision-making skills
Knowledge of ISO9001
Proficient in document control practices in a regulated environment
Nice to have:
Knowledge and or use of Oracle Enterprise Resource Planning (ERP)
Experience working with senior-level executives as well as individual contributors to drive change and influence processes.
Proficiency in defining/creating business reports using relevant tools
Experience with SQL
Experience with Oracle ERP
Ability to assess and manage risks associated with configuration changes, and an understanding of risk management standards, such as ISO 14971.
Understanding of validation and verification processes and activities
Understanding of medical device regulations and standards, such as ISO13485, FDA 21CFR Part 820, MDR, MDSAP
Experience with change management in medical devices.
This position is open to all candidates.
