Actalent
Orangeburg, NY, USA
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....


