Engineer I, Source Quality, Orthopedics

Johnson & Johnson • Warsaw, IN

22h • Hybrid

About The Position

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 MedTech, 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 jnj.com . 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. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics 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 Companies is a member of Johnson & Johnson's Family of Companies and is recruiting for an Engineer I, Source Quality to be located in Warsaw, IN . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech 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 .

Requirements

• A minimum of a Bachelor's or equivalent university degree in Engineering or related Scientific focus is required
• 0-2 years of related experience
• Excellent problem solving and decision-making skills
• Communication/Interpersonal skills and flexibility to enable resolution of technical situations

Nice To Haves

• Relevant work, internship, or Co-Op experience
• Experience or knowledge with manufacturing processes; machining, injection molding, additive manufacturing and/or electronics manufacturing
• Medical Device and/or Pharmaceutical industry
• Six Sigma, Lean, or ASQ Certification/training
• Quality engineering experience
• Experience with Blueprint reading/literacy including GD&T
• Familiarity with inspection methods and techniques
• Knowledge of FDA CFR Part 820 and ISO 13485
• Experience with process validation

Responsibilities

• Under the direction of a Sr. Engineer, the Engineer I, Provides quality engineering leadership in the management of select External Manufacturers, Direct Material, and Indirect material suppliers.
• Responsible for technical leadership in establishing quality expectations at the supplier.
• Implements, and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, process performance metrics).
• Partner with product development teams to support successful launches at suppliers.
• Conduct supplier visits emphasizing quality improvement and compliance with good manufacturing practices, ISO-13485 and other applicable standards.
• Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities.
• Contributes to root cause investigations using various problem-solving techniques and tools, and assesses corrective action effectiveness.
• Applies various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).
• Communicate at all levels within Quality and across functions or departments such as R&D, Regulatory, Manufacturing, and Marketing.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees