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12262 Quality Engineer I (Pune)

Ecolab · Pune

📅 20/08/2026
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DUTIES AND RESPONSIBILITIES: - Coordinate and plan supplier audits in conjunction with the global supplier quality, Quality Manager, procurement team, RD&E; and Internal stakeholders. - Conduct ISO9001 and ISO13485 (including any applicable specific requirements) audits for suppliers based on the plan / business urgency. - Communication with suppliers on action plan preparation/review. Follow-up to the action plans resulting from these audits. - Lead or support root cause investigation of nonconformities and develop, initiate, or implement corrective actions. - Conduct periodic review and analysis supplier actions using quality tools including, but not limited to: FMEA, DFMEA, PFMEA, DQ, IQ, OQ, PQ, control plans, process verification/validation plans, equipment qualification, PDA, Cpk, SPC, statistical process control and DMAIC. - Develop, implement, and ensure that the supplier conforms to customer, internal, regulatory/legal, and certifying organization requirements. - Manage the documentation by creating, update, and control - Responsible for activities involved in supplier quality assurance. - Prepare and provide reports, communications and/or presentations to management around the development / status of Audits. - Manage and support activities related to alternate supplier approval and product specification enhancements. - Lead and support quality activities including FMEA, SPC, Internal/External audit support, SCAR, and Corrective & Preventative Actions. QUALIFICATIONS: - Minimum of a bachelor degree in a related discipline (Chemical engineering /Biotech engineering /production engineering/ Pharmacy etc.) and / or master degree in Chemistry/ Quality / Purchasing / Supply Chain Management. - Lead Auditor Certification for ISO9001, ISO13485 and relevant standard. - Must have considerable experience in conducting ISO, GMP audits for regulatory and non-regulatory industry by onsite/remote mode. - Understanding of Lean, 6 sigma green belt. - 3+ years of experience .
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