Quality Assurance Executive

2 weeks ago


Vadodara Gujarat, India The HR Factory Full time

Job description: Q A Executive

1. Regulatory Excellence:

- Ensure strict adherence to medical device industry regulatory standards.
- Manage documentation for ISO 13485 and CE certification compliance.

2. Documentation Oversight:

- Monitor and enforce documentation compliance across all departments.
- Develop and implement standardized SOPs as needed.

3. Global Certification Preparation:

- Lead efforts for obtaining CE and US FDA 510 K certificates.
- Streamline certification processes with relevant stakeholders.

4. Internal Audits and Improvement:

- Conduct internal audits and MRMs for continual improvement.
- Implement corrective actions based on audit findings.

5. Training and Readiness:

- Develop training programs for quality standards and procedures.
- Ensure the team is audit-ready for both regulatory bodies and customers.

**Job Types**: Full-time, Regular / Permanent

Day range:

- Monday to Saturday

**Education**:

- Graduate preferred

**Experience**:

- Background in Regulatory affairs of Medical Device company preferred
- Should be fluent in English language

**Salary**: ₹35,000.00 - ₹60,000.00 per month

**Education**:

- Bachelor's (preferred)

Ability to Commute:

- Vadodara, Gujarat (required)

Ability to Relocate:

- Vadodara, Gujarat: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**
+91 9978850153



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