QA Engineer

Key Responsibilities:
1. Drive Consistent Excellence in Final Product Quality
 Conduct in-process and final product inspections to ensure product conformance.
 Manage product testing, calibration, and validation processes.
 Investigate product deviations and implement corrective and preventive actions
(CAPA).
2. Quality Systems & Process Control
 Establish, implement, and maintain Quality Management Systems (QMS) in
compliance with ISO,CE, FDA and other regulatory standards.
 Define and monitor quality control checkpoints across the production process.
 Drive continuous improvement in quality and process reliability.
3. Supplier Quality Management
 Evaluate and audit suppliers to ensure compliance with company quality standards.
 Work closely with procurement and production teams to resolve quality issues
related to materials and components.4. Documentation & Compliance
 Prepare and maintain all quality-related documentation, reports, and audit trails.
 Ensure compliance with regulatory and certification standards (ISO 9001, ISO 13485,
CE, FDA etc.).
 Lead internal and external audits with certification and regulatory bodies.
5. Cross-Functional Collaboration
 Work closely with R&D, Production, and Operations teams to implement quality best
practices.
 Support the product team in defining specifications and quality criteria during design
and development.
Requirements:
 Bachelor’s degree in Engineering, Quality, or related technical field.
 3–5 years of experience in Quality Assurance / Quality Control in a product
manufacturing or health-tech company.
 Hands-on experience with QMS implementation, ISO standards, CAPA, and audits.
 Strong understanding of quality tools such as FMEA, Root Cause Analysis, and 5
Whys.
 Excellent analytical, documentation, and communication skills.
 Attention to detail with a problem-solving mindset.
experience6