Program Manager, One Quality Management System

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Date: Jun 3, 2023

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 8060

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.

Position Summary

The Program Manager is responsible for driving the enterprise to a single, consolidated, electronically available, fit-for purpose QMS that enables speed, transparency, and effective Quality Management. They will define and drive strategic objectives to actions and deliverables through methodical planning, resourcing, executing, and controlling these projects from start to finish. The Manager will take program ownership while guiding their team and cross-functional groups through execution by ensuring consistent and compliant practices throughout all phases of the life cycle and across functional teams.

Principal Responsibilities

•   Lead 1/eQMS project and team
•   Define and communicate project resource requirements and negotiate with functional managers to obtain resources necessary to support assigned programs
•   Monitor project budgets, directing the efficient use of resources to effectively complete projects
•   Present program status to Management regularly
•   Cultivate a high performing work team culture among project core teams.
•   Partner with various entity QMS Leads and Teams to ensure a harmonized approach for consolidating Quality Management Systems
•   Host workshops to collaborate with Quality System Leads and process map current state of Quality System elements across the enterprise
•   Identify and implement Key Performance Indicators to reflect process effectiveness, speed and efficiency
•   Identify workload drivers and complexity factors of Quality System element processes
•   Host workshops to collaborate with Quality System Leads and develop desired future state accounting for best practices observed across Quality Systems and industry standard practice
•   Develop process to create or revise procedures including a gating mechanism
•   Partner with cross-functional leads and vendors to develop and implement requirements for an eQMS
•   Support training content and delivery
•   Identify/escalate any compliance issues and their potential impact across Teleflex and provide potential solutions/actions so that they can be effectively resolved.
•   Interface with all sites and site stakeholders for QMS architecture questions
•   Analyze Key Performance Indicators across the enterprise to ensure process compliance
•   Identify, propose and lead continuous improvement opportunities as it relates to QMS architecture
•   Lead or support additional local or global project as assigned by Quality and Regulatory Leadership

Education / Experience Requirements

•   BS in technical discipline or equivalent education/experience required
•   10 years of demonstrated experience in quality or compliance working in a multi-site company in the Medical Device industry
•   Experience with Quality Management Systems. Strong knowledge of FDA 21 CFR, EU Medical Device Regulation and other global medical device regulations and standards including but not limited to International standards ISO 13485, ISO 14971.
•   Experience consolidating Quality Management Systems

Specialized Skills / Other Requirements

•   Must have advanced-level project management and process improvement skills.
•   Strong influence management skills. Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals
•   Excellent verbal/ written communication and presentation skills. Demonstrated ability to succinctly and accurately communicate to various levels of management and across the organization
•   Ability to support multiple projects and balance priorities, work independently or collaboratively to determine and develop solutions
•   MS Project, Excel, PowerPoint, SharePoint skills
•   Exceptional facilitation, analytical, planning, organization and time management skills to effectively execute project plans
•   Excellent decision-making skills. Ability to negotiate and balance decisions and manage competing priorities across multiple functional areas
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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®, 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.