Regional Manager Sterility Assurance

Date: Jan 28, 2023

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 7115


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


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 incumbent in this role is responsible for managing the resources required to assure compliance and quality related to sterility assurance and re-usable cleaning/sterilization processes.

Principal Responsibilities

•    Provide tactical leadership and direction for Teleflex by managing the Sterility Assurance Department team consisting of varying levels of professionals to provide shared services to all business units across Teleflex.
•    Lead and provide expertise as the sterilization subject matter expert (SME) for Teleflex and its various divisions.
•    Responsible for maintaining the sterility assurance database for Teleflex and assuring compliance to relevant domestic and international standards (if applicable).
•    Represent Teleflex and interface with FDA and third-party auditors/investigators during audits as the SME for sterilization, microbiological and environmental controls for manufacturing facilities.
•    Manage department resources to work with teams to launch new products and assess design changes for existing products.
•    Manage department resources to provide sterilization, microbiological and environmental control expertise during supplier quality audits of critical suppliers/vendors.
•    Manage department resources to provide microbiological expertise for environmental controls of existing and newly built class cleanrooms and other controlled manufacturing environments.
•    Manage resources to assure compliance with ISO standards for the various product lines and sterilization processes. 
•    Assure annual requalification activities and quarterly dose audits are performed in a timely manner so that no supply chain interruptions occur.
•    Create process maps and perform gap analyses for sterilization and microbial processes as needed.
•    Manage resources necessary to have compliant and validated cleaning and sterilization processes for re-usable instrumentation (if applicable).
•    Develop and maintain reusable cleaning/sterilization database for Teleflex Medical products to be used and reference in products evaluation (if applicable).
•    Manage resources responsible for re-usable cleaning/sterilization evaluations and/or validations for Teleflex Medical projects, including, new products and existing product improvement, and new markets (if applicable). 
•    Develop protocols, technical reports and directs validation, as necessary for re-usable cleaning/sterilization (if applicable).
•    Maintain re-usable cleaning/sterilization related procedures current per relevant domestic and international standards (if applicable).
•    Maintain contact and able to negotiate with laboratory and consultant suppliers.
•    Assure that product/process control methods for use are validated prior to publication.
•    Provide leadership and expertise to close CAPA's and non-conformances; reduce sterilization non­ conformances via creation of a quality culture.
•    Support the maintenance of harmonized procedures used globally.
•    Provide support to in-house microbiology and chemistry labs to provide efficient and compliant work processes, as these labs provide support to several manufacturing locations.
•    Develop and lead strategic initiatives to improve cycle time and sterilization processes/efficiencies, such as conversion to parametric release, consolidation of sterilization families and cycles, creating overlap and redundancy between existing cycles and new cycles during cycle development.
•    Lead all aspects of talent management (i.e. recruiting, performance management, development)

Education / Experience Requirements

•    B.S. degree in Science (Microbiology, Biology, Medical Technology, etc.) required. M.S. or M.B.A. preferred.
•    ASQ CQA or COE or 6 Sigma certified preferred
•    Minimum 7-10 years experience in sterilization and laboratory operations. 
•    Experience in EO and gamma radiation sterilization and re-usable sterilization is preferred.
•    Minimum of 5 years of management of exempt employees which included technical oversight required. Experience supervising laboratory staff preferred.

Specialized Skills / Other Requirements

•    Regulatory, cGMP, QSR, knowledge base.
•    Statistical Knowledge (DOE, SPC, Hypothesis testing, Sample Comparison).
•    Computer literate (i.e., data-base development, statistical software and analysis, word processing for report generation, etc.)
•    Negotiation and problem-solving skills.
•    Ability to operate and communicate effectively with multiple teams.
•    Supplier auditing skills, (i.e., ASQ-CQA, internal/ external courses, seminars).
•    Knowledge and experience in Sterilization (especially EO and gamma radiation).
•    Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts

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.

© 2021 Teleflex Incorporated. All rights reserved.