Senior Quality Assurance Specialist

hace 2 días


Juárez, Chihuahua, México Johnson & Johnson A tiempo completo
About the Role

We are seeking a highly skilled Senior Quality Technician to join our team at Johnson & Johnson in Juarez, Chihuahua, Mexico. As a key member of our quality team, you will play a critical role in ensuring the development and implementation of quality-engineered systems and products that meet the highest standards of excellence.

Key Responsibilities
  • Assist in the development of quality control and risk management plans for new product development, sustaining, and supply chain quality projects.
  • Write and execute process and product validation protocols and reports, equipment qualifications, and engineering change orders.
  • Analyze data using statistical tools to make acceptance decisions and improve process capability.
  • Ensure that development activities follow design control requirements and product testing meets applicable standards.
  • Support quality improvement initiatives, including legacy product improvement, continuous improvement, and customer satisfaction.
  • Plan and execute product acceptance activities, including inspection instructions, equipment and gage requirements, and sampling plans.
  • Support vendor audits and supplier quality activities as needed.
  • Investigate and resolve Corrective and Preventative Actions (CAPA) and assist in complaint analysis.
  • Collaborate with Regulatory Affairs to develop submissions for process changes, inspection changes, and new processes/devices.
Requirements
  • Bachelor's degree in a related field, with a minimum of 1-3 years of quality, manufacturing, or research and development experience in a medical device or regulated industry.
  • American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
  • Familiarity with GD&T concepts and ability to develop and implement quality standards.
  • Knowledge of quality and operations systems and processes, including GMP and QSR requirements for medical devices.
  • Problem-solving skills, verbal and written communication skills, and ability to effectively communicate with internal and external personnel.


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