Global Manager, CAPA

Date: Sep 9, 2021

Location: Remote, NC, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 4276

 

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

This position is required to assess and provide a clear global vision of CAPA compliance across the Teleflex organization through driving strategy, direction, management and oversight of the global corporate CAPA program.

This person will be responsible for:

•    Ensuring that the CAPA Policy, Procedure and Work Instructions meet all applicable requirements, regulations, and standards, including but not limited to Regulations for Australia, Brazil, Canada, Japan, United States FDA 21 CFR and European Medical Device Directive, EU MDR, and ISO 13485.
•    Conducting analysis of all CAPA activity to ensure timely completion of CAPA plans, generation of accurate records, and approval of CAPA activities.
•    Managing the analysis of trends across products, processes, facilities and functions.
•    Coordinate regional and global CAPA meetings, including the maintenance of all related quality records.
•    Developing CAPA mentors globally that can act as Subject Matter Experts for CAPA.
 

Principal Responsibilities

•    Provide strategic oversight to the CAPA program at each Teleflex Medical site and managing a training and qualification program for site resources who manage and lead CAPAs.
•    Develop and maintain the Global CAPA policies and procedures to maintain compliance to applicable regulations and the CAPA Strategic Plan.
•    Responsible for developing CAPA training content and ensuring training is implemented at all sites.
•    Manages the Global CAPA Review Board and ensures that CAPAs meet all Teleflex and external regulatory requirements.
•    Identify and escalate any compliance issues and their potential impact across Teleflex so that they can be effectively resolved.
•    Provide supervision and training, as required for direct reports to manage CAPA. Support direct reports in gaining knowledge of all applicable standards, regulations, Teleflex policies, procedures and work instructions, as per individual development plan.
•    Responsible for collection, production, and publication of compliance data and metrics related to CAPA to Teleflex leaders as a health assessment of the Global CAPA program.
•    Interface with all sites and site stakeholders for technical assistance and problem solving in areas of CAPA, as needed.
•    Analyze the CAPA metrics within or across product lines, processes, facilities, suppliers, or functions. Ensure metrics are complete and accurate for management review. Initiate CAPAs for adverse trends.
 

Education / Experience Requirements

•    Bachelor’s degree or equivalent.
•    7+ years of experience in quality or compliance working in a multi-site company in a regulated industry with strong experience in corrective and preventive action. 
•    Experience with Quality Management Systems. Strong knowledge of FDA 21 CFR and global medical device regulations and standards, including but not limited to MDD Regulations, International standards ISO 13485, ISO 14971.
 

Specialized Skills / Other Requirements

•    Demonstrated strong expertise with multiple root cause analysis and problem solving methodologies.
•    Fluent in English (written and verbal)
•    Working knowledge of Risk Management and CAPA systems.
•    Project Management Experience as project sponsor or lead.
•    Experience developing and leading Strategic improvement plans to business process flows.
•    Experience and/or ability to manage cross-functional team meetings; train or coach other employees; and give short presentations.
•    The ability to establish rapport with internal and external customers, peers, and employees in all departments.
•    Excellent organizational skills.
•    Excellent written and verbal communication skills.
 

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.

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