2 jobs found in Orangeburg

Job Title: Senior Quality EngineerJob Description The Senior Quality Engineer is responsible for leading quality assurance initiatives, ensuring that processes, products, and systems comply with regulatory and company standards. This position serves as a technical resource for cross-functional teams, focusing on complaint handling, non-conformance reports (NCRs), root cause analysis, and leading audits. Responsibilities Perform quality activities in support of operations, contract manufacturers, and R&D. Support design and engineering change processes and associated documentation. Support internal and external audit activities and work to resolve audit nonconformities. Lead quality activities related to Corrective and Preventive Action (CAPA) processes. Represent Quality Engineering in the development and maintenance of process and product risk assessments. Participate in Material Review Board reviews, including material segregation,...

We are seeking an experienced Sr. Quality Engineer to lead quality assurance initiatives within a medical device manufacturing environment. This role ensures compliance with regulatory and company standards and serves as a key technical resource for cross-functional teams. You will be the sole Quality Engineer onsite in Orangeburg, NY, collaborating closely with remote quality leadership and engineering teams. Key Responsibilities Perform quality activities supporting operations, contract manufacturers, and R&D. Lead quality activities related to CAPA processes and NCRs. Support internal and external audits; resolve audit nonconformities. Represent Quality Engineering in risk assessments (e.g., FMEAs) and maintain risk management documentation per ISO 14971. Participate in Material Review Board reviews, including segregation, investigation, and disposition. Design and implement robust quality controls for new and existing processes....