Job Title: Quality Manager Quality Assurance

Location: Kolkata, India

Your Role

Responsible for leading Quality Assurance activities, Quality Management Systems (QMS), and continuous improvement initiatives across manufacturing operations. The role will ensure compliance with global quality standards, customer satisfaction, regulatory requirements, and effective implementation of quality processes across products and operations.

Main Responsibilities

- Quality Management System (QMS) & Compliance

Lead and manage the Quality Management System (QMS) to ensure compliance with ISO 13485:2016 and global quality standards.

Develop, review, update, and maintain quality documentation including Quality Manuals, SOPs, procedures, and process documents.

Plan and conduct internal audits, prepare audit reports, and ensure closure of audit findings through effective CAPA actions.

Conduct Management Review Meetings with leadership teams and functional heads.

Drive continuous improvement initiatives to strengthen quality systems and operational excellence.

- Customer Quality & Complaint Management

Understand customer requirements and establish effective quality controls aligned with global guidelines.

Manage customer complaint processes and ensure timely investigation and resolution.

Analyze market feedback, return lenses, and quality issues to identify improvement opportunities.

Establish return product verification processes and provide quality assessment reports.

Drive customer satisfaction improvement initiatives in collaboration with cross-functional teams.

- Product Quality & Process Improvement

Monitor product quality performance and drive key quality improvement indicators.

Lead quality improvement projects and corrective action plans with Production, Technical, and Operations teams.





Conduct product and process validation activities including Risk Assessment, IQ, OQ, and PQ validations.

Support Current Product Introduction (NPI) activities by ensuring quality requirements are met before product commercialization.

Monitor Product Control Plans (PCP) and ensure adherence to quality standards.

- Supplier Quality & Development

Establish supplier qualification processes and monitor supplier quality performance.

Define quality requirements for raw materials and intermediate products.

Conduct supplier audits and ensure compliance with company quality standards.

Drive supplier improvement initiatives through corrective and preventive actions.

- Training & Capability Development

Develop and conduct training programs on product knowledge, quality processes, and compliance requirements.

Support teams in improving technical capabilities and quality awareness.

Promote a strong quality culture across the organization.

- Cross-Functional Collaboration

Collaborate with Production, Maintenance, Technical, Supply Chain, HR, EHS, and Global Quality teams.

Support process standardization and documentation improvements across departments.

Coordinate with cross-functional teams for risk assessment, change management, and process improvements.

Ensure products and processes meet quality, safety, and regulatory requirements.

- Quality Analytics & Continuous Improvement

Analyze quality data, failures,



trends, and customer feedback to identify improvement opportunities.

Use quality tools such as Lean Six Sigma, SPC, and problem-solving methodologies.

Drive data-based decision-making and quality improvement initiatives.

Identify opportunities to improve processes, reduce defects, and enhance efficiency.

Candidate Profile

Experience

12-15 years of experience in Quality Assurance / Quality Management within manufacturing industries. Experience working in a multinational workplace preferred. Experience in Medical Devices, Optical, Healthcare, or manufacturing industries preferred.

Technical Expertise

Strong knowledge of ISO 13485:2016 Quality Management System.

Experience in internal audits, CAPA management, risk assessment, and compliance systems.

Knowledge of Lean Six Sigma, Continuous Improvement tools, SPC, and quality problem-solving techniques.

Experience in customer complaint handling and resolution.

Proficiency in MS Office, Excel, PowerPoint, Power BI, and SAP.

Educational Qualification

Bachelor's or Master's degree in Science or equivalent qualification.

Key Skills

Strong analytical and problem-solving skills.

Excellent understanding of quality control procedures and regulatory standards.

Strong attention to detail and result-oriented approach.

Excellent communication and presentation skills.

Strong stakeholder management and cross-functional collaboration skills.

Ability to lead quality improvement projects independently.

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Quality Manager - Quality Assurance (Bengaluru)
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