JD : • Lead the supplier qualification process by assessing manufacturing/technology capabilities. • Conduct comprehensive gap assessments at target suppliers to identify areas for improvement and create individual supplier development plans. • Work with suppliers and run SCN and PPAP activity • Develop and refine comprehensive training materials to effectively deploy problem-solving, process control, and quality tools. • Proactively identify and implement continuous improvement activities to prevent the recurrence of non-conformities, ensuring sustained process enhancements. • Review supplier manufacturing processes and collaborate with suppliers on process improvement and value enhancement opportunities. • Facilitate root cause analysis and corrective actions of supplier quality issues. • Independently work with suppliers for the completion of PPAP, Special Process Validation IQ, OQ and PQ requirements. • Knowledge of International standards relative to QMS, ISO 9001:2015, ISO 13485, and ASTM/ASME standards are preferred. • Strong knowledge of Supplier Qualification, Supplier Production Part Approval Process (SPPA), conducting Product and Process Audit at the supplier end • Tailor strategies based on supplier and activity feedback to ensure maximum deployment effectiveness. • Collaborate with cross-functional teams to develop and enhance the overall supplier development process and phased rollout plans. • Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers and deliver quality awareness training to suppliers. • Monitor supplier progress and performance against pre-agreed objectives and goals, providing guidance and support as needed.
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Qualification: • Bachelor's degree in engineering B. Tech / B.E preferred (E.g., Mechanical Engineering or equivalent) or a related field. • 5-10 years of experience in Supplier Quality Engineering, preferably in the Medical Device Industry. • Language Proficiency • Strong ability in interpreting engineering drawings/prints. • Proficiency in quality tools, risk analysis and statistical tools for problem-solving. • Willingness and ability to undertake travel at the supplier end on a need basis. • Exceptional verbal, written, presentation, and interpersonal skills. • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)