Director, RAQA Strategic Manufacturing

Date: Jul 19, 2021

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 4341

 

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 is a Key Position in the execution of strategic projects in Global Operations.  There are a number of projects being initiated to drive Teleflex’s profitability and operational excellence into the future.  This role is an integral part of a team with responsibility for executing these projects in line with our values without compromise on Quality of products or customer’s needs. 
This position requires a senior Quality Assurance and Regulatory Affairs leader with the ability to manage a very broad set of activities.
 

Principal Responsibilities

•    Ensure appropriate quality assurance and regulatory strategies are defined and implemented related to all manufacturing transfer projects as determined by Global Operations team. This includes proper regulatory filing determinations for the US, European, Japanese and other international markets.  
•    Develop appropriate systems and methods to facilitate global registration of manufacturing transfer activities.  Stay abreast of evolving regulatory requirements in foreign markets. 
•    Ensure proper facility registrations and device listings with appropriate regulatory agencies.
•    Anticipate emerging regulations and issues and develop solutions to them with key stakeholders. Identify need for new quality and regulatory policies/processes. 
•    Detailed analysis, review and tracking of all aspects of quality assurance associated with manufacturing transfers.
•    Ensure proper communication and act as liason and partner with Global QARA to insure project success.
•    Lead QARA M&A due diligence and integration programs. 
•    Attract, retain and develop people within the team. 
•    Develop and manage budgets as they apply to the role.
•    As with all positions, due to the dynamic nature of Teleflex Medical Business, key responsibilities will evolve and change over time.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

•    Key Relationships / Interfaces: Include all interrelationships 
     Corporate VP Quality & Regulatory
     Global VP Regulatory
     Global VP Operations Quality
     VP Strategic Manufacturing
     BU Quality and Regulatory
 

Education / Experience Requirements

4 Year Degree in a technical field, MS Degree Preferred
•    Extensive knowledge and understanding of US and international medical device regulations, standards and guidance documents.
•    Extensive Project Management skills and experience.
•    Lean Six Sigma, CQE, CQA, ASQ certifications preferred
•    Write and edit regulatory documents, persuasive writing
•    Regulatory, cGMP, QSR knowledge and ability to work within/navigate with ease
•    Functional Expert in Quality/Regulatory understanding with a passion for excellence.
 

Specialized Skills / Other Requirements

•    Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts
•    Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.
•    Excellent communication skills – both written and verbal and ability to present Reports & Ideas.
•    A Leader, innovative and imaginative with a forward - looking approach and commercial outlook.
•    Displays ownership of results and a drive to achieve.
•    Fluent in English.
•    Self-driven and ability to work independently and/or as a team player.
•    Approachable and enthusiastic. Flexible and adaptable.
•    Good organisational skills with cultural awareness and sensitivity.
•    Good judgement and problem-solving ability and capable of understanding the impact of decision making on both Teleflex Medical and its customers.
•    Strong collaboration and influencing skills – both internally and externally.
•    Goal orientated for customer and business objectives.
•    Coaching/mentoring 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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Raleigh