Expected Travel: Up to 25%
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.
Global Operations is a complex and diverse organization within the company which is responsible for product fulfillment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Quality, Service and Value as perceived by our customers.
We focus on attracting, developing and retaining the best people at all levels of our organization to deliver our commitments to our customers.
This is a key position in the development and execution of Merger & Acquisition(M&A) processes in Global Operations.
This position requires a QA Leader with the ability to manage a very broad set of activities, as described below:
• Develop and implement a QARA due diligence process for the robust execution of M&A activity.
• Ensure appropriate quality assurance strategies and regulatory strategies are defined for integration activities.
• Stay abreast of quality management system changes and regulatory changes, notifying the key stakeholders of changes that may impact the due diigence process or planned integrations.
• Ensure compliance to Global quality management system requirements, Quality System Regulation (QSR), CMDCAS, ISO 13485, European Medical Device Regulation and other applicable Standards.
• Ensure that all critical to quality aspects of the product are clearly identified and remediation activities performed during integration.
• Ensure that product quality is maintained or improved during integration.
• Ensure effective communication and act as a partner with due diligence and integration teams.
• Represent QARA at due diligence gate reviews, clearly articulating the QARA conclusions.
• Demonstrate initiative and critical thinking to resolve problems and work with the applicable team to resolution.
• Exemplify Teleflex Core Values that ensures a fair, open and productive climate.
• Ensure an ethical and legally compliant atmosphere.
• Provide other support requested by management
• Adhere to and ensure the compliance of Teleflex's Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
Education / Experience Requirements
• Microbiology, Biology, Medical Technology or Other Appropriate 4 Year Degree.
• 8+ year's experience in Quality Assurance and/or Regulatory Affairs
• Knowledge and understanding of US and international medical device regulations, standards and guidance documents.
• Extensive knowledge and understanding of ISO13485, 21CFR820 quality management system requirements.
• Project Management skills and experience.
• People management skills and experience.
• Lean Six Sigma, CQE, CQA, ASQ certifications preferred
Specialized Skills / Other Requirements
• Ability to influence people and change.
• Excellent verbal and written communication skills;
• Experience with leading and participating in several projects concurrently.
• Ability to accurately scope projects and consider the full impact of decisions and actions taken.
• Effective presenter of issues, facts and ideas to senior members of the organization.
• 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.
• cGMP, QSR knowledge and ability to work within/navigate with ease
• Ability to communicate, escalate issues and to present reports & ideas.
• Functional expert in quality and/or regulatory with a passion for excellence.
• A leader, innovative and imaginative with a forward looking approach and commercial outlook.
• Displays ownership of results and a drive to achieve
• Must be fluent in English.
• Complex problem solving skills for developing creative solutions and meeting objectives are required.
• Manage personnel directly or indirectly to achieve the objectives of the applicable project.
• Self motiviated to achieve compliant results.
• Good business acumen.
• Attention to detail and accuracy - essential.
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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