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J&J Family of Companies Design Quality Engineer II in Warsaw, Indiana

DePuy Synthes, a member of the Johnson & Johnson family of companies is recruiting for a Design Quality Engineer II in Warsaw, IN.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

As the Design Quality Engineer II, you will apply basic Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments. Participates in and performs tasks on projects and assignments with technical responsibility or strategic input. Receives intermittent, detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.

The Design Quality Engineer II should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. You should 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.

Your responsibilities will include, but are not limited to:

  • Core team member of new product launch team working with product development, marketing, and manufacturing.

  • Interacts with suppliers or internal manufacturing on production of implants or instruments. Coordinates and facilitates process verification/process validation activities for suppliers.

  • Demonstrates competency to apply various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process improvements.

  • Demonstrates competency to apply various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, and effects analysis).

  • Contributes to the reliability assessments of product design.

  • Contributes to root cause investigations using various problem solving techniques and tools, and assesses effectiveness of corrective actions.

  • Conducts, and supports the development of, test methods in equipment, process, and product qualifications/validations.

  • Ensures that process Quality control plans are in accordance with product risk level and are consistently followed.

  • Contributes to, implements, and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).

  • Participates in technical reviews as appropriate.

Qualifications

Education:

  • A minimum of a Bachelor's degree or equivalent degree is required preferably within Engineering, Technical, or Scientific discipline. An Advanced degree in a related field is an asset.

    Experience and Skills:

  • A minimum of 2 years of experience is required, preferably within a regulated environment (e.g. FDA regulated).

  • Basic knowledge of Quality Engineering/Scientific methods and techniques is required

  • Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred.

  • Quality Engineering/Design or Process Excellence/Lean experience is an asset.

  • Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.

  • Basic technical understanding of manufacturing equipment and processes is preferred.

  • Basic understanding and application of measuring techniques (for example mechanical, optical, gages, automation) is required

  • Experience managing tasks or small projects and demonstrating project leadership abilities.

  • You should have the ability to work independently and partner with a multi-functional team.

  • Problem solving techniques including root cause analysis and cause and effect analysis are all preferred.

  • Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.

  • ASQ certifications are an asset.

  • May require up to 20% travel.

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-Indiana-Warsaw-700 Orthopaedic Drive

Organization

Medical Device Business Services, Inc (6029)

Job Function

Engineering

Requisition ID

2105940973W

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