New Product Quality Engineer-3973140911
Description
VISTAKON® is currently recruiting for a New Product Quality Engineer. This position will be based in Jacksonville, FL and may require up to 10% domestic or international travel, based on business needs.
VISTAKON®, a division of Johnson & Johnson Vision Care, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUE® family of products. Our associates around the world are committed to expanding the ACUVUE® brand, and fortifying our position as the worldwide leader in the contact lens industry.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The New Product Quality Engineer performs the following quality and technical functions associated with new product introduction: Supports qualification projects preparing risk assessments, protocols, reports, test scripts, and test reports. Develops and performs procedures associated with facilities, equipment, instrument, and process qualifications. Supports early technology research by participating as the QA representative in, preliminary hazard analysis, clinical risk assessments, and by reviewing and approving technology research plans and clinical build protocols.
Collaborates with cross-functional project teams in the creation, review and archiving of Design Control deliverables for new product introductions in the electronic Design History File. Provides supplier quality audit support for R&D. Maintains quality systems especially for R&D Change Control process. Participates in the utilization of Team center, Knowledge Management, System related primarily to the eDHF and Validation libraries. Adheres to safety and environmental policies and procedures and supports department safety and environmental objectives.
Primary Roles & Responsibilities:
65% - Partners with scientists and engineers to define and execute Design Control and Process Validation activities for new product introductions.
20% - Provides Quality Engineering support to R&D for Change Control and Supplier Quality.
10% - Provides subject matter expertise in use of Team Center Application.
5% - Performs other related duties as assigned by management.
Qualifications
A minimum of a Bachelor’s Degree is required, preferably in Mathematics, Statistics, Engineering, or related Science. A minimum of 2 years related work experience is required. Experience with Quality Systems in a highly regulated environment is required. Experience in the medical device industry is preferred.
Practical understanding and application of principles, concepts and practices of Design Controls, and Risk Management is preferred. A general understanding of GMP/ISO regulations, validation/qualification principles is required. Working knowledge of Team center (Siemens PLM) is preferred. Strong communication, interpersonal and organizational skills are required.
This position will be based in Jacksonville, FL and may require up to 10% domestic or international travel, based on business needs.
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J2W:LI NA
Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)
Job Function: Quality (Eng)
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