R&D Document Specialist II

Position Summary

The R&D Document Specialist plays a crucial role in ensuring the efficient management of Teleflex products, throughout the various stages of Product Lifecycles Management (PLM) for R&D.  This role is focused on meticulously preparing, evaluating, and expediting R&D documents using Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) systems. The specialist ensures R&D documents are complete, accurate, and compliant within these systems, serving as a Subject Matter Expert (SME) for R&D in PLM and document control processes.

Principal Responsibilities

•    R&D Subject Matter Expert in document change control in PLM systems
•    Partner with R&D to facilitate and guide ECO/COs in preparing, routing, approval, and release of documentation in QMS/ERP systems.
•    Support creating New Product Development (NPD) documentation in QMS/ERP systems for R&D projects. 
•    Identify and implement best practices in document control, and drive continuous improvements for R&D NPD projects.
•    Create detailed reports and queries for ECO/CO, accuracy, approvals, and throughput in QMS for R&D. 
•    Assist in monitoring process effectiveness, including the impact of changes, and recommend process improvements in PLM document control systems.
•    Generate, assign, update, and ensure accuracy of the Global Trade Identification Number (GTIN) information in applicable systems.
•    Participate in problem solving, metric reporting/improvement, and other various projects, as assigned.
•    Provide high-level customer service and support to specific cross-functional areas.
•    Participate in and/or lead special projects, as assigned.
•    Provide audit and training support, as requested.

Note: 75% of this job involves direct R&D activities
 

Education / Experience Requirements

•    Bachelor’s or technical degree in related field, degree preferred.  
•    3 + years of experience in design and development of medical devices
•    5 + years of experience in document control using PLM and ERP software, Oracle Agile/SAP preferred.
•    Working knowledge of Microsoft Word, Excel, Outlook, Adobe Acrobat
 

Specialized Skills / Other Requirements

• Excellent written and oral communication skills
• Detail oriented and self-directed with excellent time management skills
• Advanced knowledge working in quality systems and compliance processes in a regulated industry
• Advanced knowldege and skills and using PLM and ERP softwares
• Proven ability to work collaboratively and independently
• Autonmy and experiece to effectively poritize and execute projects/tasks with minimal oversight

Competencies

The incumbent must have proven abiilty to:
•    Instills Trust - Gains the confidence and trust of others through honesty, integrity, and authenticity. Follows through on commitments; is seen as direct and truthful; keeps confidences; practices what he/she teaches; shows consistency between words and actions.
•    Courage - Steps up to address difficult issues, saying what needs to be said. Readily tackles tough assignments; faces difficult issues and supports others who do the same; provides direct and actionable feedback; is willing to champion an idea or position despite dissent or political risk.
•    Decision Quality - Makes good and timely decisions that keep the organization moving forward. Makes sound decisions, even in the absence of complete information.
•    Plans and Aligns - Plans and prioritizes work to meet commitments aligned with organizational goals. Sets objectives to align with broader organizational goals; breaks down objectives into appropriate initiatives and actions; stages activities with relevant milestones and schedules; anticipates and adjusts effective contingency plans.
•    Cultivates innovation - Creates new and better ways for the organization to be successful. Comes up with useful ideas that are new, better, or unique; introduces new ways of looking at problems; can take a creative idea and put it into practice; encourages diverse thinking to promote and nurture innovation.
•    Optimizes Work Processes - Knows the most effective and efficient processes to get things done, with a focus on continuous improvement. Identifies and creates the processes necessary to get work done; separates and combines activities into efficient workflow; designs processes and procedures that allow managing from a distance; seeks ways to improve processes, from small tweaks to complete reengineering.
 

Working Conditions / Physical Demands

•    Ability to sit, stand, walk throughout the day as needed in an office and light manufacturing/assembly environment to perform tasks
•    Fine and gross motor skills to perform tasks using standard office equipment including frequent keyboarding, computers, peripherals, phones, and other devices as required
•    Ability to communicate clearly both in writing and using spoken communication, with or without assistance
•    Ability to read, comprehend, and appropriately act upon detailed written information at an advanced level, with or without assistance
•    Infrequent lifting of up to 20 pounds may be required
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