Senior Quality Engineer - Complaints Handling
Senior Quality Engineer - Complaints Handling
Posted on :
29-04-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Hybrid or OnsiteTravel Percentage: 20
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 GRRs 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:
- B. Tech / Mechanical Biotechnology with 47 years of work experience
- Hands on experience of Complaint handling and product investigations on experience of problemsolving 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:
- Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements internal processes and policies.
- Demonstrated ability to selfmotivate ability to prioritize tasks in a deadlinedriven environment.
- Demonstrated ability to effectively work with others in various coordinate disciplines and on multinational teams.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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