Quality Auditor ISO 13485

3 weeks ago


Gurgaon, India National Placement Full time

**Job description**

1. Sound understanding of system standards i.e. ISO 9001, ISO 14001, 45001, ISO 13485

2. Good command over English language to read and understand new standards and for internal and external communication

3. Experience as MR / System In charge from a medical device equipment / manufacturing organization.

4. Developing QMS related SOPs (or) helping colleagues to develop QMS documentation.

Liaise with Quality Manager to monitor and report on the performance of the Quality Management System

Establish and drive successful fulfilment of Quality Management System.

Responsible to send daily status reports and highlight risks as appropriate to the Management.

Liaise with Management to support audits.

Develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.

Monitor, investigate, and report on customer complaints.

Obtain the necessary quality system certifications. Lead audit and inspection preparation, resolution of audit and inspection findings.

Must have trained & experience for ISO 13485

Salary - 30-50K CTC

Experience 2-8 years

**Salary**: ₹300,000.00 - ₹600,000.00 per year

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Commission pay
- Performance bonus
- Quarterly bonus
- Yearly bonus

**Experience**:

- QUALITY AUDITOR ISO 13485: 2 years (required)

**Speak with the employer**
+91 9891170003
- Health insurance


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