Johnson & JohnsonRemote
Quality Systems Engineer
United States of America
Full Time
8 hours ago
$79,000 - $128,000 USD
H1B Sponsor Likely
Key skills
Quality Management Systems (QMS)ISO standardsFDA standardsQuality AuditingQuality Control (QC)Corrective and Preventive Actions (CAPA)Non-Conformance (NC) managementSix SigmaCertified Quality Engineer (CQE)Analytical ReasoningCoachingCommunication
About this role
Johnson & Johnson is a leader in healthcare innovation dedicated to improving health for humanity. The Quality Systems Engineer will develop, implement, and maintain quality management systems to ensure compliance with industry standards, while collaborating with cross-functional teams to promote continuous improvement initiatives.
Responsibilities:
- Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed
- Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards
- Conduct internal and external audits, and support the implementation of corrective and preventive actions to address identified issues
- Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team
- Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments
- Design and oversee quality processes and documentation to ensure accurate and consistent procedures are followed
- Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards
- Participate in internal and external audits, and support the implementation of corrective and preventive actions to address identified issues
- Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC), ensuring timely resolution and documentation in accordance with regulatory requirements
- Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team
- Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments
Requirements:
- Bachelor's degree in engineering, Quality Management, or a related field
- At least three years of experience working with quality systems in a regulated industry
- Comprehensive understanding of ISO, FDA, or other applicable standards
- Strong analytical, problem-solving, and communication skills
- Certification in quality management, such as Six Sigma or CQE