QUALITY ENGINEER II-8641140702
Description
DePuy Synthes Joint Reconstruction, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer II, located in Warsaw, IN.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
DePuy Synthes Joint Reconstruction is the Orthopaedic division offering a comprehensive portfolio of Orthopaedic Implant solutions for the treatment of the simplest to the most complex joint disorders using traditional and minimally invasive techniques.
The Quality Engineer II should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. This individual will work in a design team setting. This individual will support new product development from design concept through product launch activities. This individual will support design control activities for new product development efforts. This individual will develop risk assessments, design validations/verifications, inspection methodology, and acceptance for inspection sample plans as part of the project teams. This individual will support product launches involving orthopaedic implants, instruments and software. This individual will provide leadership in the understanding of medical device regulations to other disciplines.
The Quality Engineer II will perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information. This individual will have intimate knowledge of research and product development, trade secrets, government reporting and legal matters, and strategic quality initiatives. This individual will interact with external customers/contacts, including outside technical contractors, suppliers, consultants, second and third part auditors, and researchers. This individual will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.
Qualifications
A minimum of a Bachelor's degree in an Engineering, Technical, or Scientific discipline is required. A minimum of 2 years experience is required. Preferably within a regulated environment (e.g. FDA regulated) An Advanced degree in a related field is an asset. The ability to work independently and partner with a cross-functional team is required. Quality Engineering/Design or Process Excellence/Lean experience is preferred. ASQ certifications are an asset. Strong engineering skills with working knowledge of: Design and Process validation/verification activities are an asset. Experience conducting Process / Design Failure Mode Effects and Analysis is an asset. Mechanical product knowledge is preferred. Software validation knowledge is preferred. Problem solving techniques including root cause analysis and cause and effect analysis are all preferred. Statistical techniques and methods are preferred. Experience with Blueprint reading/literacy including Geometric Dimensioning and Tolerancing (GD&T) is preferred. Familiarity with inspection methods and techniques is an asset. Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred. Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
Prior project management experience is preferred. Working knowledge of Microsoft office products (Word, Excel, Access, and Project) is required. Excellent written and oral communication skills are required. The ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required.
This position will be based in Warsaw, IN, and will require up to 30% travel.
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Primary Location:North America-United States-Indiana-Warsaw
Organization: Depuy Products Inc. (6030)
Relocation: Eligible No
Travel:Yes, 25 % of the Time
Job Function: Quality (Eng)
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