puestos de Calidad en México

Johnson & Johnson is committed to health innovation, developing smarter, less invasive, and personalized treatments. We are seeking a Senior Quality Engineer for the 2nd shift in Juarez City, to contribute to our quality engineering team within the Medical Devices sector.

Participate in product and process development teams to ensure quality compliance, lead design verification, process validations, and uphold standards such as FDA, ISO 13485, and others relevant to medical devices.

• Support new product/process development, quality operations, and assurance.
• Apply Quality Engineering tools for effective product lifecycle management.
• Lead quality improvement initiatives and support continuous improvement efforts.
• Develop quality control strategies and risk management plans.
• Author and review validation protocols, reports, and engineering change documentation.
• Utilize statistical tools (Six Sigma, SPC, DOE) for data analysis and process improvement.
• Determine testing requirements for sterility, biological, and packaging standards.
• Ensure compliance with design control, testing standards, and regulatory requirements like MDR.
• Plan product acceptance activities, including qualification and sampling.
• Support vendor audits and supplier quality initiatives.
• Manage CAPA processes and assist in complaint analysis.
• Collaborate with Regulatory Affairs on submissions for process changes and new devices.
• Participate in design reviews and pre-validation assessments.
• Make independent engineering decisions and represent the organization in technical conferences.
• Consult with supervisors and provide guidance on complex problems.

• Bachelor’s degree in a related field.
• 4-6 years of experience in a quality role within the medical device industry.
• ASQ certification, Six Sigma experience, or Process Excellence knowledge is desirable.
• Knowledge of GD&T is beneficial.
• Ability to develop and implement quality standards.
• Deep understanding of GMP, QSR, and quality systems for medical devices.
• Expertise in Quality Engineering, design control, and V&V methodologies.