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1 Cyient Design & Quality Engineer Job

Software Design Quality Engineer

10-15 years

Bangalore / Bengaluru

Software Design Quality Engineer

Cyient

posted 12d ago

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 Design & Quality Engineer 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
49% more than the average Design & Quality Engineer Salary in India
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What Cyient employees are saying about work life

based on 4.2k employees
63%
93%
57%
88%
Flexible timing
Monday to Friday
No travel
Day Shift
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Cyient Benefits

Team Outings
Soft Skill Training
Cafeteria
Job Training
Health Insurance
Work From Home +6 more
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Cyient Bangalore / Bengaluru Office Locations

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Bengaluru Office
Cyient Limited, Infotech IT Park, 110/A & 110/B, Phase 1, Hosur Road, Electronics City Bengaluru
Karnataka 560100
Bengaluru Office
Cyient Limited, Pritech Park,9B,Eco Space,, Bellandur Bengaluru
Karnataka 560103

Software Design Quality Engineer

10-15 Yrs

Bangalore / Bengaluru

12d ago·via naukri.com
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