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Help maintain and continuously improve QMSR and ISO 13485-compliant QMS. Support improvements to SOPs. Participate in internal audits and support external audits (FDA, supplier). Lead or support CAPA investigations. Help develop quality metrics. Partner with Operations to help ensure manufacturing processes are controlled and validated. Contribute to risk management, and …
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Help maintain and continuously improve QMSR and ISO 13485-compliant QMS. Support improvements to SOPs. Participate in internal audits and support external audits (FDA, supplier). Lead or support CAPA investigations. Help develop quality metrics. Partner with Operations to help ensure manufacturing processes are controlled and validated. Contribute to risk management, and …
Position: Clinical Affairs ManagerLocation: Providence, Rhode IslandSummary:The Clinical Affairs Manager will lead the development and execution of clinical protocols and clinicalevaluation reports, ensuring compliance with regulatory and quality standards. Writes and implementsprotocols and plans necessary to support corporate objectives. This role bridges clinical operationswith regulatory strategy, supporting the Company’s medical …