1. Black Belt Consultants
Location: Minneapolis, MN
Duration: 9+ Months
Interview: Telephonic & Webcam discussion
Client : Healthcare/Medical Devices
Brief profile:
Black belt/ Master Black Belt, professional with processes focus
10+ years of experience in process improvements in Medical devices
Key Technical Skills:
• Experience in Process Improvement Methodologies (Six Sigma, Lean, Kaizen etc.)
• Six Sigma Black Belt - Experience in DMAIC and DMADV methodologies
• Good understanding of Medical Device industry business processes
• Executed at least 10 Six Sigma Process improvement projects
• Lead, manage and/or perform audits and inspections across Organization
Monitor non-conformances, perform trend analyses, and present findings
Brief profile:
Black belt/ Master Black Belt, professional with processes focus
10+ years of experience in process improvements in Medical devices
Key Technical Skills:
• Experience in Process Improvement Methodologies (Six Sigma, Lean, Kaizen etc.)
• Six Sigma Black Belt - Experience in DMAIC and DMADV methodologies
• Good understanding of Medical Device industry business processes
• Executed at least 10 Six Sigma Process improvement projects
• Lead, manage and/or perform audits and inspections across Organization
Monitor non-conformances, perform trend analyses, and present findings
2. Regulatory Specialist
Location: Minneapolis, MN
Duration: 9+ Months
Interview: Telephonic & Webcam discussion
Client : Healthcare/Medical Devices
Brief profile:
5 + years of experience in Medical Device Industry in Design, Development & Regulatory Compliance. For Class II and III products . Experienced in complete Product Life Cycle Management & have expertise in Embedded System Risk Management
Relevant Experience:
• Hands on experience in implementing the Medical device regulatory standards requirements during design stage and performing the pre compliance and compliance tests.
• Expert in Medical Device Risk Management activities.
• Knowledge on Medical Device Directive for Europe , PMN and PMA for FDA regulations.
Key Technical Skills
• Hands on Experience in End-to-end Medical Device Design & Development
• Involved in the complete life-cycle management from Market Requirement, Specification, Development, Verification & Validation, Product release, Field trial and Field failure analysis.
• Experience working with Medical device product such as Implantable Device , Patient Monitoring Devices, Ultrasound Scanners, Renal Dialysis Machine, Infusion Pump, Fetal Monitor etc..
• Preparing Risk management file as per the requirements by Regulatory standards.
• Hands on Experience for Pre-compliance and Compliance Testing for regulatory standards.
• Exposure to 21 CFR Part 801, 21 CFR Part 807 , 21 CFR Part 814,
• Preparing and maintaining DHF and DMR files.
• Hands on experience in preparing documentation for TF/ 510(k)/PMA filing
• Knowledge on ISO 13485, IEC 62304 and part 820 standards.
• Interacting with Notified body ( UL/TUV/CSA etc) for getting the CE mark/PMA/PMA approval.
Submission Template for the submission of the profile !!!!!
| Candidate Name | |
| SR Number / Position | |
| Present location (city, state or ZIP) | |
| Work Authorization | |
| Tel No | |
| E-mail ID | |
| Skype ID | |
| *Onsite availability (post-selection) | |
| Total onsite experience, working in US | |
| Overall relevant experience of candidate | |
| Availability for Interview (Time & Date) | |
| Rate - $$/HR including Overheads | |
| Is this profile already projected to Wipro Technologies ?, please mention the date and location of the project | |
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With Warm Regards ,
SANJAY
Snr.Resource Manager
Terminal Contacts LLC.,
Phone : 1-(813)- 864 7381
Fax : : +1 813 354 2419
Email : sanjay@terminalcontacts.com
& : hrterminalcontacts
www.terminalcontacts.com
http://www.linkedin.com/in/sanjayjavaji
Terminal Contacts LLC., is a global provider of IT recruitment, software development and IT services. We deliver a measurable delta in productivity, profitability, and shareholder value to the world's leading companies. Our Methodology enables clients to lower the total cost of ownership and meet their business objectives.
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