Stratasys is a world leader in 3D printing!
Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.
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.
