Design Quality Engineer I - Orthopedic Medical Devices

Johnson & Johnson Co.; West Chester (Chester County); On-site; USD 70,000 - 100,000; Full time

Job summary

Johnson & Johnson is seeking a Quality professional to join the Design Quality Engineering Group under DePuy Synthes for Trauma, CMF and related businesses. You will help launch and sustain orthopaedic implants and instrumentation, applying technical know-how to ensure performance, safety, and regulatory compliance.

Collaborating across R&D, Quality, Regulatory and Manufacturing, you will lead design reviews, support verification/validation and risk management, work with suppliers, and drive

Qualifications

• Minimum 1 year experience in a GMP/ISO regulated environment (including internships, co-ops).
• Proficient with Microsoft Office Suite.
• Travel up to 10% domestically, as needed.
• Fluent English language required.

Responsibilities

• Lead product realization planning for new projects and existing products.
• Conduct formal technical design reviews across the product realization process.
• Support design verification/validation activities including mechanical testing and tolerance analyses.
• Assist risk management planning, design/clinical risk management, and reporting.
• Collaborate with suppliers on qualification of new parts/processes and transfer to manufacturing.
• Support product lifecycle activities including design changes and cost improvement initiatives.
• Provide leadership in Quality System areas (CAPA, complaints, post-market surveillance, nonconforming materials, audits).
• Communicate effectively across Quality and with Product Development, Regulatory, Manufacturing and Marketing.

Skills

GMP/ISO experience

English fluent

Problem solving

Communication

Education

B.S. in Engineering/Technical Science

Tools

Microsoft Office Suite

Job description

Johnson & Johnson is seeking a Quality professional to join the Design Quality Engineering Group under DePuy Synthes for Trauma, CMF and related businesses. You will help launch and sustain orthopaedic implants and instrumentation, applying technical know-how to ensure performance, safety, and regulatory compliance.

Collaborating across R&D, Quality, Regulatory and Manufacturing, you will lead design reviews, support verification/validation and risk management, work with suppliers, and drive