Quality Executive

**Compliance with Regulatory Standards**
- Ensure that the company's quality management system (QMS) complies with industry-specific regulations, including **FDA** (Food and Drug Administration), **ISO 13485**, **CE marking**, and other applicable global standards.
- Prepare and maintain documentation necessary for **regulatory audits** and inspections.
- Stay up-to-date with changes in regulations and ensure company policies align with new requirements.

2. **Quality Management System (QMS) Implementation**
- Assist in the development, implementation, and maintenance of the **QMS** to ensure continuous improvement in quality processes.
- Manage quality-related documents such as **SOPs** (Standard Operating Procedures), **work instructions**, and **protocols**.
- Coordinate **internal audits** and assist in **external audits** conducted by regulatory authorities or notified bodies.

3. **Product Quality Assurance**
- Oversee the **validation and verification** processes for products, equipment, and processes (including IQ, OQ, PQ Installation Qualification, Operational Qualification, and Performance Qualification).
- Perform **risk management** activities (such as **FMEA** - Failure Modes and Effects Analysis) to ensure potential risks are identified and mitigated.
- Implement **corrective and preventive actions (CAPA)** to address any product nonconformities or quality system deficiencies.

4. **Supplier Quality Management**
- Evaluate and manage the quality of raw materials, components, and services provided by suppliers.
- Work closely with suppliers to ensure they meet the required quality standards through supplier audits, performance reviews, and improvement initiatives.

5. **Product Testing and Inspection**
- Ensure **incoming materials** and **finished products** are tested and inspected according to quality standards and specifications.
- Develop and oversee **sampling plans** and statistical quality control procedures to monitor product quality throughout the manufacturing process.
- Investigate and document any **product failures** or **non-conformances**, determining root causes and corrective actions.

6. **Continuous Improvement Initiatives**
- Lead and participate in continuous improvement initiatives to enhance product quality, reduce waste, and improve efficiency.
- Use tools like **Lean**, **Six Sigma**, and **Kaizen** to drive process improvements and implement best practices in manufacturing.

7. **Training and Development**
- Train employees on **quality standards**, **procedures**, and **regulatory requirements**.
- Ensure that all personnel involved in quality activities have the necessary skills and knowledge to perform their roles effectively.

8. **Complaint Handling and Post-market Surveillance**
- Investigate and manage **customer complaints** and ensure corrective actions are implemented.
- Conduct post-market surveillance to monitor the safety and performance of the product once released to the market.
- Communicate with regulatory bodies regarding any adverse events or recalls and manage the execution of recall activities if necessary.

9. **Documentation and Reporting**
- Ensure all quality-related documents, including test reports, audit reports, and validation protocols, are properly maintained.
- Prepare regular **quality performance reports** for management, summarizing audit findings, non-conformance trends, and improvements.

10. **Collaboration with Cross-functional Teams**
- Work closely with **R&D**, **production**, **regulatory affairs**, and other departments to integrate quality principles into every stage of product development and manufacturing.
- Provide quality input during **design control** phases to ensure the product meets both **design** and **quality requirements**.

**Qualification: M.Sc/B.Sc/B.Pharma/M.Pharma with minimum 1-2 years of experience in Medical device industry.**

**Job Type**: Permanent

Pay: ₹19,598.61 - ₹30,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift
- Fixed shift

Supplemental Pay:

- Overtime pay

**Experience**:

- total work: 1 year (preferred)

Work Location: In person