Teleflex Maple Grove , MN 55369
Posted 3 weeks ago
Expected Travel: Up to 10%
Requisition ID: 10183
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Interventional
Position Summary
The Senior 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.
4 + years of experience in design and development of medical devices
7 + 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 - incumbent must have proven abiilty to:
#LI-AD1
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
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
Teleflex