Senior Supplier Quality Engineer / Supplier Quality Trainer Tekone It Services Private Limited

8.0 - 12.0 years

42 - 60 Lacs

remote, india

On-site

We are seeking an experienced Supplier Quality Professional Trainer with 10+ years of expertise in managing supplier quality assurance , supplier development, and compliance in regulated industries (pharmaceutical, biotech, or medical devices). The role involves ensuring suppliers meet company , industry, and regulatory standards by leading audits, driving quality improvement initiatives , and building strong supplier partnerships. Job Responsibilities: Develop and manage supplier quality strategies, policies, and risk management processes. Lead supplier qualification, selection, and approval in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP). Conduct supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements. Oversee supplier corrective and preventive actions (CAPA) , root cause analysis, and continuous improvement programs. Collaborate with cross-functional teams (procurement, R&D, operations, quality) to resolve supplier-related issues. Monitor supplier KPIs (on-time delivery, defect rates, deviations, complaints) and drive improvement initiatives. Support new product development (NPD) by ensuring supplier capability for components, raw materials, and services. Manage supplier change control processes and evaluate impact on product quality and regulatory compliance. Train, mentor, and guide internal teams and suppliers on quality systems and compliance expectations. Ensure alignment with global regulatory requirements (FDA 21 CFR Part 11/210/211, ISO standards, EU MDR, ICH guidelines). Core Competencies & Skills Strong expertise in supplier quality management, auditing, and regulatory compliance . In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, IATF 16949 (if automotive/industrial) . Proficiency in risk management, root cause analysis, CAPA, Six Sigma, Lean methodologies . Excellent communication, negotiation, and stakeholder management skills. Ability to lead supplier development programs and strategic quality initiatives. Experience in global supplier management and multicultural environments. Qualifications: Bachelor's/Master's degree in Engineering, Life Sciences, or related field. 10+ years of experience in supplier quality assurance, preferably in pharma/medical devices/regulated manufacturing industries. Certified Lead Auditor (ISO 9001/13485, GMP, or equivalent) preferred. Six Sigma Green/Black Belt certification is a plus. Proven track record in managing global suppliers and delivering measurable quality improvements.

Posted 3 days ago

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