Head of Quality Assurance

Position Overview

The Head of Quality Assurance will lead the quality function for the organization, ensuring world-class standards in precision, product reliability, supplier compliance, and customer satisfaction. This role is critical in upholding the company's commitment to delivering accurate and dependable analytical instruments.

Key Responsibilities

1. Quality Strategy & ISO Compliance

• Establish and implement a comprehensive quality assurance strategy.
• Lead ISO 9001 compliance and certification audits.
• Ensure adherence to international and industry-specific standards.
• Define and implement the company’s overall quality assurance strategy aligned with business goals and compliance requirements.
• Foster a culture of quality and continuous improvement across all departments—especially in manufacturing, R&D, and supply chain

2. R&D Product Validation

• Collaborate with R&D to develop product validation protocols.
• Approve release of new products based on validation and reliability testing results.

3. Supplier Evaluation & Green Channel Strategy

• Conduct FAIR (First Article Inspection Reports) for all critical components.
• Implement Green Channel procurement for consistent quality suppliers.
• Develop and implement Supplier Evaluation & Rating systems, including First Article Inspection Reports (FAIR).
• Drive quality audits for new and existing suppliers.
• Lead the Green Channel Procurement Strategy by identifying and certifying high-performing vendors for streamlined, trust-based quality clearance

4. Manufacturing Quality Control

• Monitor adherence to quality standards at all manufacturing stages.
• Define test standards and acceptable deviation levels.
• Define and enforce in-process quality control (IPQC) standards and protocols.
• Ensure strict adherence to product-specific test standards with clearly defined allowable deviations.
• Oversee inspection and approval/rejection processes with proper tagging (e.g., rejection/approval stickers).

5. Product Documentation & SOPs

• Maintain and update all SOPs, test plans, and inspection documentation.
• Ensure clear traceability of every lot or batch manufactured.
• Ensure adherence to ISO 9001 (and other relevant ISO/industry standards).
• Lead internal and external audits; ensure timely closure of NCs (non-conformities) and continuous compliance.
• Act as the Management Representative for quality certifications and audits
• Oversee quality validation and reliability testing of new products developed by R&D.
• Collaborate closely with design and development teams to establish robust validation protocols before pilot and full-scale production.

6. Rejection Analysis & CAPA

• Lead root cause analysis for all product rejections.
• Implement and monitor CAPA effectiveness.
• Lead root cause analysis for rejections (internal or customer returns).
• Drive implementation of Corrective and Preventive Actions (CAPA) across departments.
• Report rejection trends and quality metrics to senior leadership.

7. Obsolescence Management

• Identify and manage obsolete parts or materials.
• Collaborate with engineering for approved alternates.
• Establish systems for tracking and managing obsolete components and products.
• Coordinate with engineering and inventory teams for alternate part approvals and updates to the BOM.

8. Customer Quality & Complaint Handling

• Lead customer complaint investigations and response.
• Monitor trends and lead proactive quality improvements.
• Lead the investigation and resolution of customer complaints related to quality.
• Ensure timely response with a structured CAPA plan and feedback loop to prevent recurrence

9. Team Leadership & Training

• Develop and mentor the QA team on tools like FMEA, SPC, 5 Whys, etc.
• Foster a culture of quality, agility, and compliance.
• Build and lead a high-performing quality team with strong focus on analytical instruments and precision manufacturing.
• Organize periodic training on quality tools (e.g., FMEA, SPC, Six Sigma) and standards.

Required Qualifications

• B.E./B.Tech in Mechanical / Electronics / Instrumentation or related field.
• 10–15 years of experience in QA, preferably in analytical/precision manufacturing.
• Strong knowledge of ISO 9001, Six Sigma, FAIR, and quality management tools.
• Software: Asana, SAP B1
• Excellent leadership, communication, and problem-solving skills.