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| COMPANY | :SMC LTD | |
| ROLE | :Quality Engineer | |
| VACANCY | :7+ | |
| QUALIFICATION | :BE Biomedical Engineering | |
| EXPERIENCE | :Freshers | |
| SALARY | :₹ 2,40,000 - ₹ 6,20,000 Per Year | |
| LOCATION | :Bangalore, Karnataka |
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ABOUT COMPANY :
- Founded in 1988, SMC Ltd. was built on a vision to provide high quality manufacturing services faster than industry options of the day. This core value of speed-to-market is what has grown SMC into a globally recognized contract manufacturer. From our early days, SMC’s core competency was injection molding based on scientific principles. This baseline of tooling and molding set the direction of providing single use and single patient finished devices across the Medical, Diagnostics and Pharmaceutical markets that SMC serves today.
- Our global locations in California, Wisconsin, Ohio, Massachusetts, Costa Rica, and India allow us to provide complete custom device services ranging from initial design, tooling, component manufacturing, assembly, automation, full supply chain management and packaging services focused entirely on healthcare markets. Our UK location provides customized or platform autoinjectors suited to the needs of drug delivery. Full contract manufacturing of these devices can be provided from an SMC manufacturing location.
- Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to top medical OEM’s in the diagnostics, pharmaceutical and medical device markets. Services include program management, product launch/scale-up, product design, engineering, prototyping, strategic supply chain management, custom thermoplastics component manufacturing, assembly, reagent filling, pouching, pre-packaged drug handling, automation, testing, and packaging.
- SMC’s team of engineers, quality, and manufacturing services, can work with you to reduce risk, accelerate lead-times, and increase speed-to-market on even the most challenging finished devices. With years of medical manufacturing experience, SMC can provide a path for prototype development, bridge development/production and full production to achieve your product launch goals.
- With operations spanning the United States, Costa Rica, and India, and over 700,000 sq. ft. dedicated manufacturing space, SMC is positioned to assist you on your next finished medical device.
- Whether your need is drug delivery, diagnostics, or medical device, SMC’s exclusive focus on the medical market, combined with over 25 years contract manufacturing experience, allows SMC to offer expert knowledge for your finished device.
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- Founded in 1988, SMC Ltd. was built on a vision to provide high quality manufacturing services faster than industry options of the day. This core value of speed-to-market is what has grown SMC into a globally recognized contract manufacturer. From our early days, SMC’s core competency was injection molding based on scientific principles. This baseline of tooling and molding set the direction of providing single use and single patient finished devices across the Medical, Diagnostics and Pharmaceutical markets that SMC serves today.
- Our global locations in California, Wisconsin, Ohio, Massachusetts, Costa Rica, and India allow us to provide complete custom device services ranging from initial design, tooling, component manufacturing, assembly, automation, full supply chain management and packaging services focused entirely on healthcare markets. Our UK location provides customized or platform autoinjectors suited to the needs of drug delivery. Full contract manufacturing of these devices can be provided from an SMC manufacturing location.
- Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to top medical OEM’s in the diagnostics, pharmaceutical and medical device markets. Services include program management, product launch/scale-up, product design, engineering, prototyping, strategic supply chain management, custom thermoplastics component manufacturing, assembly, reagent filling, pouching, pre-packaged drug handling, automation, testing, and packaging.
- SMC’s team of engineers, quality, and manufacturing services, can work with you to reduce risk, accelerate lead-times, and increase speed-to-market on even the most challenging finished devices. With years of medical manufacturing experience, SMC can provide a path for prototype development, bridge development/production and full production to achieve your product launch goals.
- With operations spanning the United States, Costa Rica, and India, and over 700,000 sq. ft. dedicated manufacturing space, SMC is positioned to assist you on your next finished medical device.
- Whether your need is drug delivery, diagnostics, or medical device, SMC’s exclusive focus on the medical market, combined with over 25 years contract manufacturing experience, allows SMC to offer expert knowledge for your finished device.
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JOB DESCRIPTION :
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- To ensure Raw Material packing material and finished goods testing in line with the SOP’s.
2. To maintain device history records (DHR) & product release checklist for each lot.
3. To conduct inspections at in-process, in-coming and completes the final inspections.
4. To prepare technical documents like DMR & DHR.
5. To maintain microbial record in ISO class-7 & class-8 as per procedure.
6. Creating master documents to track calibration & latest version of documents and records.
7. To prepare control plan, FMEA & FAIR documents.
8. To prepare 8D and supplier CAPA reports.
9. Monitoring calibration activities.
10. Perform metrology activities & drawing reviews.
11. Coordinates investigation, root cause analysis & corrective action.
12. Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
13. Gauge R&R, CpK, PpK studies, IQ, OQ, PQ validation/qualification, MSA, run charts, etc.
14. Working knowledge of the ISO 13485 & ISO 9001 standards.
15. Product & process validation requirements & implementation.
16. FAIR inspection, DHR & control of documents
How to apply :
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