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Quality Engineer - Complaints Investigation

Quality Engineer - Complaints Investigation

Sgtc India

2 - 5 years

4 - 7 Lacs

Gurugram

Posted:3 weeks ago| Platform:

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Skills Required

RCA Root cause analysis Medical devices ISO 13485 ISO 9001 Analytical Risk assessment Complaint handling Risk management QC tools

Work Mode

Work from Office

Job Type

Full Time

Job Description

What you will do: Complaint handling and Product investigations of medical devices Perform Visual, functional, dimensional, functional inspection & RCA of field returned products. Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities. Risk management -Risk assessment Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR s etc. Review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis. Other tasks as assigned by manager. What you need: Required skills: B. Tech / M.Tech Mechanical, Biotechnology with 2-5 years of work experience Hands on experience of Complaint handling and product investigations process.Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability. Hands on experience of Risk Management process as per ISO 14971 Sound knowledge on complaint handling process of medical devices will be an added advantage Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).Good understanding of FDA 21CFR Part 822 / 820 (Good to have) Preferred skilla: Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies. Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Travel Percentage: 20%

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Sgtc India

www.sgtcindia.com

Information Technology

Noida

51-200 Employees

70 Jobs

Key People

Rajesh Kumar

CEO
Anita Singh

CTO
Pooja Verma

CFO

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Quality Engineer - Complaints Investigation

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Quality Engineer - Complaints Investigation

Experience & Salary

Skills Required

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