Quality Engineer II

About the role

Johnson & Johnson is seeking a Quality Engineer II to join its MedTech team in Ciudad Juarez. The role supports new product development, sustaining projects, and supply‑chain quality initiatives, ensuring that products meet regulatory and internal standards.

Key responsibilities

• Assist in new product development, sustaining, and supply‑chain quality projects.
• Develop and execute quality control, risk management, and validation protocols.
• Write process and product validation reports, equipment qualifications, and engineering change orders.
• Apply statistical tools (Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, and improve process capability.
• Ensure design control compliance, product testing per standards, and adherence to European MDR requirements.
• Support product transfer to manufacturing, including inspection instructions, equipment, gage requirements, and sampling plans.
• Lead vendor audits and act as a franchise quality representative.
• Participate in NC, CAPA, internal audits, training, and quality system activities.
• Investigate corrective and preventive actions and assist with complaint analysis.

Required profile

• Understanding of applicable federal, state, and local regulations and corporate procedures.
• Experience with quality improvement, continuous improvement, and customer satisfaction initiatives.
• Ability to support supplier quality and audit processes.
• Strong analytical skills for data‑driven decision making.

Required skills

• Six Sigma methodology
• Statistical Process Control (SPC)
• Design of Experiments (DOE)