Quality Assurance

2 weeks ago

Dholka HO Ahmedabad Gujarat, India KK HR services Full time

**Position - QA - Manager/Executive**
**Education : Science Graduate,**
**Experience - 5 to 10 Year**

**Key Responsibilities**:

- Review and approve validation protocols and internal audit reports.
- Ensure adherence to ISO 13485 standards and other statutory requirements.
- Maintain and update company systems and documentation as per regulatory requirements.
- Address customer compliance issues and manage non-conformances identified by auditors.
- Oversee and prepare for CE and other international audits.

**Qualifications**:

- Science Graduate.
- 5 to 10 years of experience in Quality Assurance, preferably within the medical devices industry.
- Strong knowledge of ISO 13485 and regulatory compliance.
- Proven experience with internal audits and handling customer compliance.

**Preferred Skills**:

- Experience in medical devices.
- Familiarity with CE and other international certification processes.

Pay: ₹600,000.00 - ₹840,000.00 per year

Schedule:

- Day shift

**Education**:

- Bachelor's (preferred)

**Experience**:

- ISO documentation: 3 years (required)
- Total: 4 years (required)
- Medical devices: 1 year (required)

Work Location: In person

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