Remediation Engineer

Job Description

Creation/modification of process flows within the Manufacturing/Service Departments. 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. 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. Identify, investigate, and resolve operational issues to improve First Pass Yield and reduce waste. Monitor and drive corrective action 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. Experience with statistical software packages (Minitab is a plus), SAP, windchill, onePLM etc. Experience with Quality Systems and process controls in the medical device industry is desirable. Knowledge and working application of FDA, cGMP, ANSI/ISO/ASQC requirements. Knowledge and working application of technical part drawings and GD&T principles. Demonstrated application of engineering principles on individual/small projects and ability to work with cross functional teams to successfully implement quality improvement and cost reduction initiatives. Demonstrated strong analytical problem solving Root Cause Investigations, CAPA, Six Sigma, continuous improvement projects. Ability to multi-task and methodically lead/manage projects. Location: Chennai Required Skillset: Gap Assessment and Remediation for DMR, Class 2 and 3 device