Date: Oct 14, 2020
Location:Maple Grove, MN, US
Expected Travel: Up to 10%
Requisition ID: 2763
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.
Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
The Systems Compliance Specialist is responsible for supporting integration and Quality System compliance activities and projects. This position directly contributes to the efficiency of the quality integration team by building and maintaining strong cross-functional relationships and ensuring quality system and process integrity, and conformance to applicable MDR, QS and other applicable quality requirements.
• Subject matter expert in quality compliance as related to Quality System elements, system integration and process harmonization
• Support and actively engage in cross-functional projects to ensure Quality System and product compliance to MDR requirements and other applicable regulatory requirements
• Partner with appropriate integration team members to provide efficient interface with applicable systems and processes (i.e., PLM, ERP, CRM)
• Partner with Regulatory to oversee and manage IFU-to-Web process and ensuring EU MDR regulatory requirements are met and maintained
• Partner with Configuration Management to ensure accuracy of the Global Trade Identification Number (GTIN) information in the Data Sync Direct CRM and ensure integrity of master data as it relates to defined regulatory requirements
• Suggest on test and evaluation strategies for system integrations
• Ensure applicable Quality System documents (i.e., quality plans, quality agreements) are modified as appropriate throughout the life of the project to reflect project timelines, deliverables, and progress
• Facilitate and lead meetings with cross-functional, multi-site teams to identify any system and/or compliance gaps and implement solutions, ensuring MDR and Quality System compliance
• Lead system and process mapping activities to support efficiency and to ensure best-in-class QS processes are developed and maintained across regional sites
• Prioritize project activities to ensure that applicable MDR, MDSAP and integration/harmonization project timelines are met
• Write content for new procedures and modifications to existing procedures in support of harmonization activities
• Monitor and report on applicable project timelines and ensure appropriate escalations
• Apply best practice in system and process integration and ensure continuous process improvements
• Provide audit and inspection support, as requested
• Participate in and/or lead other special projects, as assigned
• Bachelor’s Degree strongly preferred
• The successful candidate will have a minimum of five years relevant experience and a high level knowledge of quality systems, compliance, database design concepts and regulatory requirements in a regulated industry.
• Working knowledge of regulatory requirements, including MDR, MDSAP
• Demonstrated ability to support system deployment or migration programs
• Demonstrated ability to support process integration and harmonization initiatives
• Demonstrated ability to lead and execute projects and related activities
• Excellent verbal, written communication and platform presentation skills
• Detail oriented and self-directed with excellent time management skills
• Outstanding customer service skills with ability to collaborate with individuals at a variety of levels across multiple cross-functional areas
• Results oriented with the ability to be accountable to the achievement of both individual and team goals
• Ability to train wide variety of audiences on new processes and/or system improvements
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: 262-439-1894.
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
2020 Teleflex Incorporated. All rights reserved.
Nearest Major Market: Minneapolis