Sr. Configuration Management Specialist

Expected Travel: None

Requisition ID: 10401

 

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 Sr. Configuration Management Specialist is responsible for performing tasks that drive the timely release and change of product documentation and supporting data throughout the product’s lifecycle. This position supports day-to-day planning and operation to ensure the Configuration Management team meets its required level of service. This position will supervise the daily activity of the Configuration Management team and will contribute to their career development and annual performance review. Additionally, this position will evaluate and process electronic change orders for completeness and adherence to procedures and will ensure appropriate distribution and notification. This position directly contributes to the efficiency of the Configuration Management team by building and maintaining strong cross-functional relationships and uses critical thinking to identify and understand complex problems and directly lead effort to implement appropriate solutions. 

Principal Responsibilities

•    Subject matter expert in change control as it relates to product lifecycle
•    Facilitate the timely change, approval and release of product documentation and data (PLM, ERP)
•    Maintain new Item Master set-up and other related data in applicable ERP
•    Support development of new documentation and provide detailed reports, queries or summaries in support of various cross-functional projects and initiatives.
•    Provide high level customer service and support to specific cross-functional areas
•    Assist in monitoring process effectiveness including the impact of changes and take the initiative to recommend process improvements and ensure procedures are in place to classify and maintain appropriate records
•    Utilize visual management and participate in problem solving, metric reporting/improvement, and other various projects, as assigned
•    Site point of contact for PLM User Account Management, coordinates and aligns training requirements with Quality Systems Training personnel.
•    Site point of contact for PLM configuration changes, coordinates with IT to implement changes.
•    Site point in contact for MDR related projects.
•    Apply best practices in change control, configuration management and continuous process improvements.
•    Participate in and/or lead special projects, as assigned.
•    Provide audit and inspection support, as requested.
•    Subject matter expert in record management and retention as it relates to quality system records and business records
 

Education / Experience Requirements

•    Bachelor’s Degree preferred
•    The successful candidate will have a minimum of five years of relevant experience and a high-level knowledge of quality systems, compliance, and change control requirements in a regulated industry.  
•    Broad functional expertise in change control management
 

Specialized Skills / Other Requirements

•    Excellent written and oral communication skills.
•    Detail oriented and self-directed with excellent time management skills.
•    Working knowledge of quality systems and compliance in a regulated industry.
•    Advanced database skills and experience with PLM and ERP software.
•    Subject matter expert (SME) in change control and product lifecycle management.
•    Outstanding customer service skills with ability to collaborate with various cross-functional areas.
•    Ability to participate in development of new documentation for quality systems proce