Systems Analyst II

4 weeks ago

Plymouth, United States Ampcus Full time

Notes from the manager - These candidates will be doing a lot of work within Windchill. The candidates submitted must have Windchill experience and highly experienced with Microsoft tools. Strong knowledge of 21 CFR 820, 21 CFR Part 11 and ISO 13485 is a must.
• Overseeing and facilitating Change Review Board meetings to ensure change requests are properly documented, reviewed, and approved/rejected.
• Overseeing and facilitating Change Implementation Board meetings to ensure plans to implement approved and verified changes are complete, appropriate, and properly executed by the operations implementation team.
• Creating appropriate tasks in the Product Lifecycle Management (PLM) system to execute approved design changes included the proper sequencing of implementation and maintenance of records documenting design changes.
• Supporting New Product Introduction teams in DHF and DMR releases. Of critical importance is to ensure adequate support prior to critical project gates and milestones.
• Performing periodic review and collaborates updates of C&CM procedures as peripheral tools and performs test of PLM tool as needed.
• Supporting PLM software updates by participating in demonstrations, UATs, training sessions and updating procedures. Review implementation plans and/or updates to peripheral tools or processes that may affect the way of working with the PLM system. Working with PLM end users to provide guidance on best practices and ways of working.
• Bachelor of Science degree in a Technical, Science, or Engineering discipline
• Working knowledge of 21 CFR 820, 21 CFR Part 11 and ISO 13485
• Experience with Windchill PLM required
• Advanced Microsoft Office skills: Word, Forms, Mail Merge, Index and Tables Excel: Forms, Formulas, & Graphs
• Strong attention to detail and a customer-first attitude
• Strong organizational skills and ability to prioritize workflow to meet established timelines.
• Ability to coordinate the work of others, monitor work for accuracy and provide appropriate feedback as needed.
• Strong interpersonal, communication skills to drive timely and accurate results.
• Proven experience working with product and process change implementation.
• Ability to maintain and apply knowledge of procedures, products, key employee contacts and activities of assigned area.
• Ability to work under pressure and on multiple tasks.
• Systematically analysis of problematic situations and develops solutions consistent with organization objectives and procedures.

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