AQE- Lead_GURGAON_DELHI NCR
-------- Original Message --------
hI
Kindly send me your updated profile if you are comfortable with below JD.
Position is in Delhi, NCR so candidates interesting in DELHI, NCR CAN ONLY APPLY.
Mandatory:
• Exposure to Medical Device validation.
• Hands on experience with SDLC and HDLC
• Able to do risk assessment for medical devices using FMEA
• Able to do Bug Life cycle management
• Hands on Software Knowledge and experience are must. Someone who can work with the product and the development team
• Advanced understanding of Quality and Quality Systems for Medical Devices.
• Experience in performing internal audits to verify compliance to documented procedures.
• Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
• Well versed with software testing/QA concepts
• Able to understand interdependencies and relationships among many software components and between several software products
Secondary:
• Understanding of any of these standards will be a big plus –
o US FDA quality regulations 21CFR part 820
o US FDA 21 CFR Part 11
o ISO 13485 standards
o IEC 60601
o IEC 62304
o FDA 510K
• Experience in developing the overall quality approach for new products and line extensions within the new product development and specials process. This includes quality engineering oversight, quality systems implementation including test and inspection plans and product reliability during product.
Regards
Neetu
neetu.goyal@tekishub.com
-------- Original Message --------
| Subject: | AQE- Lead_GURGAON_DELHI NCR |
|---|---|
| Date: | Wed, 01 Jun 2011 18:59:35 +0530 |
| From: | Tekishub Consulting Services Pvt. Ltd. |
Experience required for Job: 7 - 12 years
Job Annual Salary: Not Mentioned
Job location: Delhi/NCR
hI
Kindly send me your updated profile if you are comfortable with below JD.
Position is in Delhi, NCR so candidates interesting in DELHI, NCR CAN ONLY APPLY.
Mandatory:
• Exposure to Medical Device validation.
• Hands on experience with SDLC and HDLC
• Able to do risk assessment for medical devices using FMEA
• Able to do Bug Life cycle management
• Hands on Software Knowledge and experience are must. Someone who can work with the product and the development team
• Advanced understanding of Quality and Quality Systems for Medical Devices.
• Experience in performing internal audits to verify compliance to documented procedures.
• Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
• Well versed with software testing/QA concepts
• Able to understand interdependencies and relationships among many software components and between several software products
Secondary:
• Understanding of any of these standards will be a big plus –
o US FDA quality regulations 21CFR part 820
o US FDA 21 CFR Part 11
o ISO 13485 standards
o IEC 60601
o IEC 62304
o FDA 510K
• Experience in developing the overall quality approach for new products and line extensions within the new product development and specials process. This includes quality engineering oversight, quality systems implementation including test and inspection plans and product reliability during product.
Regards
Neetu
neetu.goyal@tekishub.com
Disclaimer:
The sender of this email is registered with naukri.com as Tekishub Consulting Services Pvt. Ltd. (asif@talentprollc.com, Plot No.33, Prashant Nagar Colony, Malakpet, HYDERABAD, Andhra Pradesh - 500036) using Naukri.com services. The responsibility of checking the authenticity of offers/correspondence lies with you.
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