Quality Engineer II
Teleflex

Job Info

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Expected Travel: Up to 10%

Requisition ID: 7828

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.

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

The Quality Engineer II is responsible for improving quality, production, and processing methods and controls in manufacturing to achieve operational excellence. This position requires the ability to build and maintain strong relationships with manufacturing engineering, material planning, and production in order to work and communicate across various levels of the organization. This position, under the direction of the Senior Quality Engineering Manager, works closely with R&D, Supply Chain Management, and Manufacturing to support day-to-day operations. The role is integral in the process validation of new products as they move through development and into production.

Principal Responsibilities

• Determine test requirements, test methods, sample sizes and statistical analysis for qualification / verification studies for manufacturing.
• Develop verification, validation and qualification plans and reports for manufacturing.
• Initiate and lead non-conformance investigations regarding component failures, finished goods failures, and product returns. This includes but is not limited to performing risk analysis, determining root cause, and recommending corrective action.
• Support investigation of customer complaints, including product/record investigation, health risk assessments, identification of CAPA's and report generation.
• Coordinate the Change Impact Assessment activities
• Support site initiatives such as Cost of Quality, Defects Per Million, and Continuous Improvement Projects.
• Mentor, train and provide work direction to quality engineering technicians
• Participate in pre-design freeze quality activities
• Reduces manufacturing process defects through corrections implemented.
• Revises simple updates to manufacturing or quality SOPs and other related documentation.
• Ensure company policies and procedures are followed.
• Establish and maintain effective working relationships with fellow employees.

Note: 50 % of this job involves direct R&D activities

Education / Experience Requirements

• BA/BS in Engineering or physical sciences required.
• 2 years of related experience required.

Specialized Skills / Other Requirements

• Demonstrates an in-depth understanding of functional area (process statistics, risk management, metrology, and calibration, ISO13485, FDA QSRs.)
• Mastery of computer software programs such as Microsoft Word, Excel, and PowerPoint
• General understanding of the quality system and regulatory compliance.

Working Conditions / Physical Demands

• Typical office environment
• Essential and marginal functions require maintaining physical condition necessary for sitting, standing, or walking for prolonged periods of time.
• Persons performing service in this position classification will exert 10 pounds to lift, carry, push, pull and/or transfer equipment and materials; considerable reaching, stooping, bending, kneeling, and crouching.
• May occasionally lift and stack heavy objects not to exceed 30 pounds; carry items up to 30 feet on distance.
• The job description documents the general nature and level of work but is not intended to be a comprehensive list of all activities, duties, and responsibilities required of job incumbents. Consequently, job incumbents may be asked to perform other duties as required.

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.

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