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Senior Research And Development Engineer
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Quality Council of India(QCI)
Project Officer
Quality Council of India(QCI) • Ahmedabad, Gujarat • via LinkedIn
16 hours ago
Contractor
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Job description
About QCI
The Quality Council of India (QCI) is a premier autonomous body set up by Government of India. QCI is responsible for creating a Quality Mindset and envisions to ensure quality across products and services that touch every citizen. As an independent and autonomous body, QCI creates a mechanism for independent third-party assessments of products, services, and processes, coordinating its...
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Quality Council of India(QCI)
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Biotech Healthcare
Senior Research And Development Engineer
Biotech Healthcare • Ahmedabad, Gujarat • via LinkedIn
13 hours ago
Full–time
Apply on LinkedIn
Apply on BeBee
Job description
> Role Objective
A key objective of this position is to support research and development activities related to medical devices and their delivery systems. The role focuses on product design, development, validation, documentation, and compliance with quality and regulatory standards, while ensuring timely execution of R&D projects and continuous improvement in product quality and processes.
> Desired Candidate Profile
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Relevant experience in medical device R&D, preferably involving IOLs or delivery systems.
• Hands-on experience with CNC machining and mechanical assembly for prototype or R&D production.
• Strong knowledge of ISO 13485, QMS, EDMS, and medical device regulatory requirements.
• Experience in design validation, process validation, and stability studies.
• Proficient in CAD software and technical documentation.
> Roles & Responsibilities
1) R&D Operations and Product Development
• Work closely with the R&D team on the development of IOLs and IOL delivery systems.
• Operate CNC machines for R&D production and perform mechanical work at R&D workstations.
• Design IOLs, injector cartridges, molded parts, blades, and other components, and generate CAD files.
• Support R&D batch planning, part production, assembly, testing, and quality control activities.
• Support commercial product stability function testing as required.
2) Design Control, Validation, and Compliance
• Prepare and maintain ISO design documents and design files for injectors and other components.
• Support ISO compliance activities and perform required tests for delivery systems.
• Conduct validation activities for delivery systems and components, including functional testing and reporting.
• Execute IQ, OQ, and PQ activities and prepare related documentation.
• Support sterilization validation, stability
Project Officer
Quality Council of India(QCI) • Ahmedabad, Gujarat • via LinkedIn
16 hours ago
Contractor
Apply on LinkedIn
Apply on BeBee
Apply on Jobs Trabajo.org
Job description
About QCI
The Quality Council of India (QCI) is a premier autonomous body set up by Government of India. QCI is responsible for creating a Quality Mindset and envisions to ensure quality across products and services that touch every citizen. As an independent and autonomous body, QCI creates a mechanism for independent third-party assessments of products, services, and processes, coordinating its...
Report this listing
Quality Council of India(QCI)
AmbitionBox
3.3/5
246 reviews
Glassdoor
3.1/5
342 reviews
Indeed
3.7/5
26 reviews
qcin.org
More jobs at Quality Council of India(QCI)
See web results for Quality Council of India(QCI)
Biotech Healthcare
Senior Research And Development Engineer
Biotech Healthcare • Ahmedabad, Gujarat • via LinkedIn
13 hours ago
Full–time
Apply on LinkedIn
Apply on BeBee
Job description
> Role Objective
A key objective of this position is to support research and development activities related to medical devices and their delivery systems. The role focuses on product design, development, validation, documentation, and compliance with quality and regulatory standards, while ensuring timely execution of R&D projects and continuous improvement in product quality and processes.
> Desired Candidate Profile
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Relevant experience in medical device R&D, preferably involving IOLs or delivery systems.
• Hands-on experience with CNC machining and mechanical assembly for prototype or R&D production.
• Strong knowledge of ISO 13485, QMS, EDMS, and medical device regulatory requirements.
• Experience in design validation, process validation, and stability studies.
• Proficient in CAD software and technical documentation.
> Roles & Responsibilities
1) R&D Operations and Product Development
• Work closely with the R&D team on the development of IOLs and IOL delivery systems.
• Operate CNC machines for R&D production and perform mechanical work at R&D workstations.
• Design IOLs, injector cartridges, molded parts, blades, and other components, and generate CAD files.
• Support R&D batch planning, part production, assembly, testing, and quality control activities.
• Support commercial product stability function testing as required.
2) Design Control, Validation, and Compliance
• Prepare and maintain ISO design documents and design files for injectors and other components.
• Support ISO compliance activities and perform required tests for delivery systems.
• Conduct validation activities for delivery systems and components, including functional testing and reporting.
• Execute IQ, OQ, and PQ activities and prepare related documentation.
• Support sterilization validation, stability
