Senior Supplier Quality Engineer / Supplier Quality Manager - Male and Female

Job Title : Senior Supplier Quality

Location : Bengaluru, Karnataka, India

Employment type : Part-time

Job Summary :

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 the 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

Qualifications :

Proven track record in managing global suppliers and delivering measurable quality improvements.

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Skills Required

Auditing, Iso 13485, Root Cause Analysis, Gmp, supplier quality management , Capa, Risk Management, Iso 9001, Regulatory Compliance, Six Sigma