Configuration Control Admin

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 doin

g:
Change Manageme

• nt-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 standar
• ds.Facilitate Change Control Board (CCB) meetings and relevant change management cross-functional and cross-platform activiti
• es.Provide and document existing and new users' training on the ECO proce
• ss.Provide ongoing support and guidance to users to ensure proper system usa
• ge.Develop and maintain documentation, including configuration management plans, policies, and procedures, to establish a structured framework for configuration contr

ol.
Regulatory Complia

• nce-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 regulati
• ons.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 implementat

ion.
Continuous improve

• ment-Lead and support continuous improvement activities to reduce variation and waste to acceptable ta
• rgetsIdentify develop, and document standard work procedures related to configuration control, change control process, and product lifecycle manag
• ementCreate and manage business reports to track product and process data, identify trends for optimization, and monitor KPIs related to configuration control and change manage

ment.
Must have for this

• role:5+ years of experience in engineering change mana
• gement3+ years of experience with Agile Product Lifecycle Management (PLM) so
• ftwareLeadership
• skillsStrong analytical, problem-solving, and decision-making
• skillsKnowledge of I
• SO9001Proficient in document control practices in a regulated envir

onment
Nice t

• o have:Knowledge and or use of Oracle Enterprise Resource Plannin
• g (ERP)Experience working with senior-level executives as well as individual contributors to drive change and influence pro
• cesses.Proficiency in defining/creating business reports using relevan
• t toolsExperience w
• ith SQLExperience with Ora
• cle ERPAbility 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 act
• ivitiesUnderstanding of medical device regulations and standards, such as ISO13485, FDA 21CFR Part 820, MDR
• , MDSAPExperience with change management in medical

devices

Travel requ

ired: 10%What​ ​you​ ​will​ ​be​ ​p

• art​ ​of: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/sustai
• nability/Our Locations - https://www.stratasys.com/en/contact-us/office-l
• ocations/Check out our Video - https://www.youtube.com/watch?v=6w