Remediation Engineer

• 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