Terumo Medical Cooperation Somerset , NJ 08873
Posted Yesterday
Job Summary:
The Quality Systems Engineer II drive TMC's Corporate CAPA Program to ensure it is compliant with applicable global Quality System regulations (i.e., 21 CFR Part 820, ISO 13485:2016, MDR etc.), effective, and efficient in dealing with quality issues.
Job Details:
Support the management and effectiveness of the Quality Management System, primarily the CAPA system by:
Establishing and maintaining CAPA process metrics
Providing guidance to CAPA Teams
Participating on CAPA Teams as needed
Reviewing content of CAPA root cause investigations, corrective actions, effectiveness criteria, and supporting data for adequacy, logicality, completeness, and compliance to regulatory and procedural requirements
Being responsible for approving corrective and preventive action plans, implementation of required activities and objective evidence, and effectiveness verification
Teaching and mentoring CAPA owners on root cause analysis and technical writing
Organizing the Stewardship reviews of CAPA documentation
Managing the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant manner.
Facilitating activities related to the CAPA Board Work with Organizational Stakeholders to ensure CAPA and other quality system requirements are well understood appropriately incorporated into CAPA documentation and Management Review
Generate Quality System Standard Operating Procedures as required.
Contribute to the development of Quality System training materials and deliver training where applicable.
Contribute to the development of Quality System performance measures.
Support FDA & third-party audits as required.
Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
Other duties as assigned.
Position Requirements:
Knowledge, Skills and Abilities (KSAs)
Background Experience:
Nearest Major Market: New Jersey
Terumo Medical Cooperation