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Job: Quality Engineering Lead, Technosoft Innovations, Morrisville, NC


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General Information

(3707608)

Job title: Quality Engineering Lead
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Job location: Morrisville, NC  27560 United States
Requisition code: QEL_Feb2018
Date posted: 02/09/2018
Compensation:
Job category:Engineering
Medical Affairs
Product Development
Quality Assurance
Employment type:Full time
Contractor
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Job Description


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Technosoft Innovations, Inc. (www.technosoftinv.com) is an end-to-end electronic product development company located in Morrisville, NC. We have an immediate open position for a Quality Engineering Lead for medical devices and electronic product development. .

Job Title: Quality Engineering Lead
Position: Full-time
Experience: 10 Years+
Location: Raleigh, NC
Qualified candidates – please email your resumes to: bishu@technosofteng.com
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Job Requirements


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Requirements

• Total Experience - At least 10 years of Industry experience in Quality & Regulatory Affairs in medical device design services
• Expertise in Medical Device Development, Documentation, and ISO 13485 Regulations.
• Experience in management of complete Product Development Life Cycle, Concept, Design, Prototyping, Testing, and Transition to Manufacturing
• Experience in product compliance testing and Certification for ISO 14971, IEC 60601-1 and collateral standards, IEC 62304
• Experience in Medical Device documentation for FDA submission such as, requirements, specifications, risk analysis, and V&V activities, IEC, UL, CE
• Experience in developing and maintaining a quality system to meet ISO and FDA regulation
• Experience in CAPA process, internal audits, vendor selection and evaluation, and risk management
• Leadership and insight during new product development to ensure that quality requirements are clearly defined and consistent with the product classifications
• Quality Management Systems
• FDA QSR for Medical Devices
• EU Medical Device Directives
• Apply Quality Engineering tools such design verification, statistical techniques and problem solving
• Assist with the interpretation of quality requirements for various products
• Engineering Management including project management skills
• Knowledge of Biocompatibility Testing (ISO 10993)
• Quality Engineer for all Medical Device Design Projects. Implement the current Medical Design Quality Management System (QMS)Obtain and continue to maintain stand-alone certification to the ISO 13485 standard for Design Engineering;
• Trainer for Medical Design QMS
• Served as management representatives for ISO13485 Audits, worked on SOP’s, Forms and Internal Audits, Experience in Customer Audits for ISO 13485 and medical design projects
• Willing to travel on Short term onsite assignments to customer sites and other Design Centers
• Education Qualification - Bachelor / Masters of Science Engineering

Qualified candidates – please email your resumes to: bishu@technosofteng.com
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