Design Quality Engineer II

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Quality

R&D/Scientific Quality

Professional

Warsaw, Indiana, United States of America

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

DePuy Synthes (Johnson & Johnson Med Tech) is recruiting for a CPD/LCM Design Quality Engineer II to be located in Warsaw, IN. The Design Quality Engineer II, applies basic Quality Engineering/Scientific Method techniques and principles to daily tasks and activities under general supervision. In addition, applies relevant regulations, standards, and industry best practices to assignments. The Quality Engineer participates in and performs tasks on projects and assignments with technical responsibility or strategic feedback.

They receive intermittent, detailed instructions from technical Quality leaders at different levels, in addition to other partners. The Quality Engineer should excel in an environment that encourages teamwork, change, risk-based decision-making and flexibility. Also, they should be able to communicate effectively with Quality leaders and other departments such as R&D, Regulatory, Manufacturing, and Marketing.

• Works with Product Development, CxE, Manufacturing, Supplier Quality, Post Market, Regulatory, MTO, and Marketing on product and process improvement projects for implants and instruments.
• Assists with the creation or update of assorted design control, process control, risk management, inspection, test, marketing, and regulatory documents.
• Supports process verification/validation activities for suppliers.
• Proven proficiency applying various tools and methods (e.g., Six Sigma, Lean) to identify and realize new product or process introductions as well as process improvements.
• Proven proficiency applying a variety of risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, and effects analysis).
• Collaborates on the reliability assessments of product design.
• Run root cause investigations using various problem solving methods and tools, and assesses effectiveness of corrective actions.
• Support the development of test methods in equipment, process, and product qualifications/validations.
• Ensures that process Quality control plans are aligned in accordance with product risk level and are consistently followed.
• Implements and/or maintains, production and process controls using appropriate methods (process capability measures, statistical process controls, and process performance metrics).
• Participates in technical reviews as appropriate.

• University/ Bachelor's degree or equivalent required
• Advanced degree or focused degree within Engineering, Technical, or Scientific field preferred

• Minimum of two (2) years of relevant work experience required, preferably within a regulated environment (e.g. FDA regulated)
• Basic knowledge of Quality Engineering/Scientific methods and techniques
• Basic technical understanding of manufacturing equipment and processes
• Basic understanding and application of measuring techniques (for example mechanical, optical, gauges, automation)
• Experience leading tasks or small projects and demonstrating project leadership abilities
• Ability to work both independently and partner with a multi-functional team

• Knowledge of the QSR, Design Controls, and ISO quality…