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CooperVision Inc Senior Quality Engineer - Paragon in Phoenix, Arizona

This job was posted by http://www.azjobconnection.gov : For more information, please see: http://www.azjobconnection.gov/ada/r/jobs/3966222

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world?s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com

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Who We Are

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Paragon Vision Sciences, Inc., a Cooper Vision specialty eye care company, is a world leading manufacturer of specialty contact lenses and oxygen permeable contact lens materials. Our CRT? lens (a class three medical device) is considered the lens of choice by many eye care professionals around the world. Paragon?s office is located in Gilbert, Arizona.

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Why Work With Us

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We are certified as a Great Place to Work?! Our environment recognizes each employee as a vital member of the team. Integrity and respect are fundamental to our working relationships. We are friendly, inventive, and dedicated. We don?t quit until the job is done right! Our lenses don?t just change vision, they change lives. Join a team that is passionate about improving other?s visual health and quality of life.

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Job Summary:

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Responsible for ensuring that products and processes meet all requirements established by global guidelines and regulatory authorities. Provide support to R&D, Regulatory Affairs, manufacturing, Marketing, etc. on design controls, risk management, verification and validation practices, and statistical methods assurance to support product and process development and manufacturing of medical devices in an environment that embraces teamwork, change, risk-based decision making and flexibility.

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Essential Functions & Accountabilities:

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? Develop, implement/ maintain procedures for Design Control that adheres to FDA Quality System Regulation, ISO 14971 and ISO 13485 standards.

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? Support and review Design Control activities for new products or process development, including design and development planning, design reviews, design input output, design verification/validation, design history files, design transfer, risk management, etc. Coordinate the development of product DHF.

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? Utilize risk-based approach to assess and control design and manufacturing changes.

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? Provide quality engineering support in design and development of medical device products to ensure that quality requirements are translated into product and process functional specifications. Provides technical leadership to support product transfers and launches in compliance with Design Control and other applicable procedures.

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? Develop and/or review of product/process development documentation, method validation documentation, software/computer system validation documentation, and process validation documentation.

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