Continuous QA/RA Enterprise Excellence Engineer
Date: Sep 16, 2023
Location: Morrisville, NC, US
Company: Teleflex
Expected Travel: Up to 10%
Requisition ID: 8746
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
** REMOTE **
This role will report to the Director of Enterprise Excellence for the global Quality Assurance and Regulatory Affairs (QA/RA) organization. This role will support implementation of the Enterprise Excellence strategy to global QA/RA. This individual will partner with key global stakeholders to build a high performing management system that ensures a quality culture and the best experience for our customers and our employees while focused on continuous improvement
Principal Responsibilities
• Help develop an Enterprise Excellence management system to move Teleflex to world class. This is accomplished through the research, development, and deployment of proven tools and techniques globally.
• Partner with global stakeholders to drive Continuous Improvement efforts as assigned. This includes, but is not limited to, project management, kaizen events, value stream mapping, development or revision to processes (QMS or Business), training, communication, and implementation responsibilities.
o Initial areas of focus include support of QA/RA technical training, support of QA/RA project management, support of one QMS project, and support of regulatory projects.
o Eventually moving towards providing business analytics support to prioritize efforts to develop and advance a high-performance Lean culture, Lean principles, and practices and subsequent ownership of continuous improvement efforts.
• Due to the dynamic nature of continuous improvement, key responsibilities will evolve and change over time and be assigned by the manager.
Education / Experience Requirements
• Must possess a degree in Engineering or related field.
• Must have a minimum 8+ years of combined practical experience in process improvement, managing projects, and/or lean implementation
Specialized Skills / Other Requirements
• Excellent communication and presentation skills.
• Experience with Lean principals preferred.
• The ability to influence without authority.
• Ability to guide senior management to ensure consistent messaging.
• Excellent organizational, time management, and planning skills.
• Working knowledge of International Quality and Regulatory requirements is preferred (FDA’s 21 CFR Part 820, ISO 13485, Council Directive 93/42/EEC, MEDDEV, MDD/MDR, Canadian Medical Device Regulations, Japanese JPAL requirements.)
• Proven track record of successful process improvements resulting in improved safety, quality, productivity, and cost.
• Strong Project Management skills and experience leading virtual teams.
• Strong analytical thinking, data analysis, and reporting skill.
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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.