Quality Engineer I, Orthopedics Supplier Quality

Johnson Johnson; United States; On-site; USD 65,000 - 85,000; Full time

Job summary

Johnson & Johnson is recruiting for an Engineer I, Source Quality, Orthopedics, to be located in Warsaw, IN. The role focuses on quality leadership across supplier networks within DePuy Synthes, guiding external manufacturers and materials quality expectations.

You will work under Sr. Engineer direction to implement control strategies, support product development launches, and ensure compliance with GMP and ISO-13485 standards while traveling up to 25% as needed.

Qualifications

• 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

Responsibilities

• 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.

Skills

Problem solving

Communication skills

Interpersonal skills

Education

Bachelor's degree in Engineering

Tools

Blueprint reading

GD&T

Job description

Johnson & Johnson is recruiting for an Engineer I, Source Quality, Orthopedics, to be located in Warsaw, IN. The role focuses on quality leadership across supplier networks within DePuy Synthes, guiding external manufacturers and materials quality expectations.

You will work under Sr. Engineer direction to implement control strategies, support product development launches, and ensure compliance with GMP and ISO-13485 standards while traveling up to 25% as needed.