Configuration Control Specialist

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 Specialist 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.
  
  

• 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.
  
  

• 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.
  
  

• 5+ years of experience in engineering change management
• 3+ years of experience with Agile Product Lifecycle Management (PLM) software
• Experience with change management in medical devices
• Leadership skills
• Strong analytical, problem-solving, and decision-making skills
• Solid understanding of medical device regulations and standards, such as ISO13485, FDA 21CFR Part 820, MDR, MDSAP
• Knowledge of ISO9001 & ISO 13485
• Proficient in document control practices in a regulated environment
  
  

• 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
  
  

• Company Overview - https://www.stratasys.com/en/about-us/history/
• Our Culture and Values - https://www.stratasys.com/en/about-us/culture/
• Our Sustainability “3D Printing a Better Tomorrow” - https://www.stratasys.com/en/about-us/sustainability/
• Our Locations - https://www.stratasys.com/en/contact-us/office-locations/
• Check out our Video - https://www.youtube.com/watch?v=6wmDfmt2bNI