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hace 2 días
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.
- 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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