Quality Assurance Officer

4 weeks ago


New Delhi, India Madhu Instruments Full time

Inspection & testing of incoming raw material as per specifications and prepare IAR (Incoming analysis report)
- Inspection & testing of in-process material as per specifications and prepare inspection reports
- Inspection & testing of finished products as per specifications and prepare inspection reports (certificate of analysis)
- Verify BPR (Batch production records) and complete them by attaching required test reports.
- Analysis of customer complaints related to quality issues and do the root cause analysis.
- Documentation support of R & D projects related to quality control.
- Inspection and preparation of records as per ISO & CE standards related to QC department.
- Validation & calibration of various instruments & equipment used in production and QC.
- Approval of all artworks (boxes, labels, IFUs etc) as per approved artworks.
- Preparation of SOPs related to QC department and their implementation.
- Preparation of documents and records for various audits - Drug department, ISO, CE & customer audits
- Ensuring compliance of standards and processes within various departments related to QC.
- Plan and conduct stability studies (accelerated & real time) of various devices and keep a record of the same.
- Microbiology testing of product samples and environmental monitoring.

**Requirements**:

- Work experience should be minimum 15-20 years in a medical device manufacturing organization.
- Excellent computer skills, including MS Office
- Strong communication skills, including the ability to explain and teach methodologies
- Understanding of manufacturing methods and quality standards
- Good at math and statistics
- Strong problem-solving skills
- A confident and determined approach
- Excellent organizational & time management skills
- Team player

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

**Salary**: ₹50,000.00 - ₹60,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

**Speak with the employer**
+91 8130384348



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