Work closely with operations and the business functions to ensure quality, performance of products and processes for medical devices Remediation lifecycle.
Responsibilities: • Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies. • Perform gap assessment and conduct remediation of documents with stakeholder inputs. • Experienced in FDA 510 K submissions, Nonconformance audits, EU MDR remediation processes. • Good understanding on the manufacturing specific QMS documents for Class-I, II and III medical devices. • Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA. • Creation/modification of process flows within the Manufacturing/Service Departments. • Development and maintenance Manufacturing/Service Work Instructions and related documents. • Creation/modification of fixtures, tooling, equipment and systems to support operations. • IQ, OQ, and PQ of fixtures, tooling, and equipment. • Monitor and drive corrective action, CAPA and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. • Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. • Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred. • Must be able to work well as a member of a team with the ability to adapt quickly to changes and work efficiently in a fast-paced environment.
Qualification:
Bachelor's degree in biomedical engineering/ mechanical engineering/industrial engineering background