Sr. Quality Engineer, Design Assurance
Teleflex

Expected Travel: Up to 25%

Requisition ID:3648

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

As a member of a cross-functional team, the R&D Sr. Quality Engineer is responsible for all quality issues in new product development or improvement up to and including technology transfer and commercialization. The R&D Sr. Quality Engineer ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the R&D Sr. Quality Engineer applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization

Principal Responsibilities

• Lead Quality Engineering activities in product and process design, including risk management, classification of quality characteristics, design inputs and review, technical drawings and specifications, and design verification and validation.
• Create and update design control risk management documents such as plans, hazard analyses, design and usability FMEA's, and reports.
• Use appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying data distributions, identifying relationships between variables, reliability, design and analysis of experiments, and statistical decision making.
• Apply the most relevant and useful quality philosophies throughout Design Control and its related processes. Understand and manage work to minimize cost of quality throughout the product's lifecycle.
• Ensure compliance of all practices to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.
• Apply project management tools in cost/schedule/resource planning and assist others in doing the same.
• Apply various principles and techniques for developing and organizing teams and leading quality initiatives and continuous improvement. Facilitate meetings and aspects of projects. Assist in working through resistance to change and improvement.
• Define, apply and analyze the results of customer input in the development of Design Control Documentation such as Customer Needs and Product Requirements.
• Apply supplier management principles such as supplier selection, qualification, certification, and performance improvement.
• Understand the implementation of appropriate internal, national and international requirements and standards. Perform formal and informal audits as necessary.
• Identify and communicate opportunities to train others, including conducting a needs assessment, developing curricula and materials, and determining effectiveness.
• Define, identify, and apply product and process control methods such as developing control plans, identifying critical control points, and developing and validating work instructions.
• Apply the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interpret and select variable, attribute, and zero-defect sampling plans.
• Develop and validate test methods. Identify and apply metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conduct measurement system error studies such as Gage R&R.
• Perform root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
• Contribute to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas such as those identified in this position description.
• Support Regulatory Affairs with related submissions.
• Generally apply the above concepts as required at the Departmental or Regional level, across multiple departments or facilities.

Education / Experience Requirements

• B.A. or B.S. degree in a technical discipline, such as engineering or science
• Minimum Required - Associate's or Non-technical BA or BS
• ASQ certification preferred (certified quality auditor, certified quality engineer, certified reliability engineer, certified six sigma green or black belt)
• 5 years of related experiences if candidate has Technical BA or BS
• 10 years of related experiences if candidate has Associate's or Non-technical BA or BS.

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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