Senior Document & Data Specialist

Position Summary

The Senior Document & Data Specialist is responsible for the administration and maintenance of comprehensive information into the ERP and document management applications, including all Material Master data required by Hu-Friedy locations including subsidiaries. In this position you will analyze, improve, and provide direction for the documentation and data required to support business operations (sales, marketing, accounting, production, procurement, distribution, customer service, quality/regulatory, etc.) with a focus on new product development.  You will also monitor issues, enhancements, and questions until resolution, as well as conduct training, communicate and work with all levels of management and employees. 

What We Offer You

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing:

• Competitive salaries
• Healthcare benefits 
• Tuition assistance
• Paid-time off
• Paid holidays
• Matching 401(k)
• Annual merit increases
• Annual bonus

Join us and help write our next chapter.

What You Will Do

•    Assists with the administration and maintenance of a validated electronic document management system (EDMS) to ensure compliance with applicable regulatory requirements. *

•    Supports and is knowledgeable of all areas of Hu-Friedy Operations. 

•    Serves as the primary subject matter expert in master data and document management for operations, new product development and process improvement teams. Complete understanding of material master data functionality in SAP and the impact this data has on other SAP functions (sales orders, purchase orders, etc.) as well as other systems throughout the life cycle of an item. *

•    Assigned to lead or represent the department on long term projects. *

•    Manages and processes complex change requests for new/revised quality documents, material master data changes. Assists with administering the engineering change order process by processing complex engineering change requests. Ensures requests have the appropriate supporting documentation to meet the organization’s requirements. Processes requests to be reviewed, approved and controlled per change control procedures. * 

•    Assists with administering and implementing document control practices to document control team members and the rest of the organization. Responsible for controlling, formatting, distributing, and maintaining quality system documentation such as SOPs, work instructions, specifications, safety data sheets, drawings, etc. while adhering to change control procedures for proper formatting, review and approval. * 

•    Creates and maintains ERP data including but not limited to material master data, bills of materials, routings, classification data, exclusions in the ERP system while ensuring regulatory requirements are met. Manages the data collection process by having data collected, reviewed, and approved via established workflows in document management system. *

•    Supports Regulatory UDI compliance by assisting with overseeing the data collection process as well as executing data uploads to GUDID and other external regulatory databases using a combination of a document management system, UDI SaaS solution provide, and directly interfacing with regulatory databases as needed. With a focus on new product development. Investigate and resolve discrepancies in data by working with appropriate personnel as needed. *

•    Responsible for developing and modifying scripts for the automated data entry tool to streamline processes for entry of Material Master, BOM’s, Routers, exclusions, classification database, etc. into the ERP system. *

•    Identifies and assists with implementation of departmental process improvement activities to streamline existing business processes or develop new processes. Identify potential improvements in the workflow or data management.

•    Proactively analyzes data, documents, resolves problems, and reviews work to ensure compliance with quality standards and procedures. *

•    Identifies the root cause of data errors and implements procedural corrections to ensure operating integrity of EDMS and SAP. Provides data analysis and recommendations to appropriate business units. *

•    Handle issues and requests from internal customers in a timely and accurate manner.

•    Serve as a lead auditor for the internal audit program as assigned.

•    Develops training materials for both internal and external use. Conducts end-user training on Document Control procedures and systems as needed.

•    Supports with administrating and maintaining the department’s SharePoint site and its contents.
 

Education Degree

What Will Help You Be Successful

•    Minimum one to three years of experience in a regulated environment (preferably in a medical device environment) required.

•    Minimum four of experience in an ERP environment maintaining master data, BOMs, routers, exclusions, reporting. Strong preference for experience using SAP.

•    Minimum two years of Document Control experience using an electronic document management system (e.g. MasterControl).  

•    Demonstrated ability to take initiative and work with minimal supervision while balancing a variety of tasks and priorities. Seek to help others when own work is completed.

•    Independent decision making.

•    Excellent typing, word processing, spelling, and proofreading skills.  MS Office – Intermediate Excel, Intermediate Word, Intermediate PowerPoint required. Must be able to create pivot tables and perform VLOOKUPs.
 

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