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Software Design Quality Engineer
Cyient
posted 9hr ago
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Flexible timing
Key skills for the job
Job Description
- Design quality engineer with minimum 10 years of experience in the medical device industry, specializing in product quality complaints management, regulatory reporting, new product design & development, and risk management.
- Experience in handling Medical devices including Active Devices, Software as a Medical Device, Disposables.
- Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts.
- Extensive expertise in ensuring compliance with global regulatory standards, including FDA (21 CFR Part 820) and EU MDR.
- Proven ability to navigate complex regulatory landscapes, secure product approvals, and facilitate successful product launches.
- Strong background in Biomedical Instrumentation Engineering, coupled with hands-on experience in driving cross-functional collaboration, complaint resolution, and continuous improvement initiatives.
- Proficient at leading complaint investigations, conducting trend analysis, and maintaining high standards of product quality and safety across the development lifecycle.
- Experience in DHF Gap assessments and Remediation activities.
- Experience in Medical Device SotA standard gap assessment for EU MDR and 510k projects.
- Implemented and Maintained quality systems according to ISO 13485:2016 and ISO 9001:2015. Performed Internal Quality Audits according to ISO 13485:2016 and ISO 9001:2015.
- Should Performed risk assessments according to ISO 14971:2019.
- Experience in Planning software verification and validation activities by identifying test requirements.
- Should have Worked on Technical documents like Trace matrix, STED, Design inputs, LRS.
- Should Perform Gap assessments and remediation activities for IEC 60601-1 series, IEC 62304, IEC 62366-1, ISO 11607-1, ISO 11607-2 and other medical device standards.
- Have knowledge in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Hands on experience in labeling activities based on ISO 20417 and ISO 15223-1.
Employment Type: Full Time, Permanent
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What people at Cyient are saying
Design & Quality Engineer salary at Cyient
reported by
2
employees
with 5-6
years exp.
₹9
L/yr - ₹11.5
L/yr
51%
more
than the average Design & Quality Engineer Salary in India
View more details
What Cyient employees are saying about work life
based on 4.4k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Cyient Benefits
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Cyient Bangalore / Bengaluru Office Locations
Bengaluru Office
Cyient Limited, Infotech IT Park, 110/A & 110/B, Phase 1, Hosur Road, Electronics City
Bengaluru
Karnataka 560100
Karnataka 560100
Bengaluru Office
Cyient Limited, Pritech Park,9B,Eco Space,, Bellandur
Bengaluru
Karnataka 560103
Karnataka 560103
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