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Job Information
Job title

Senior Principle Quality Engineer

Company Harvey Nash Plc
Wage Not specified
Location United States, Florida, Pinellas Park
Employment type 0-3 Month Contract
Education Not Specified
Year Experience 2 - 3 Years of Practical Experience
Travel None
Published on 9/5/2006
Description
Senior Principle Quality Engineer

We are currently seeking to fill a Senior Principle Quality Engineer position for our client in Pinellas Park, FL. We invite you to review the position requirements below and apply today if your skills match our need.

This is your chance to work for a top fast-paced technology-driven company! Our client provides its employees with opportunities for professional growth, as well as the flexibility to achieve a balance between work and personal life. Working for this company means working with teams that are involved with leading-edge research in groundbreaking areas of science and technology. It means opportunities to work with new manufacturing processes and in product development

Rate: DOE
Type: 5 months contract opportunity

Responsibilities:
- Serve as quality product development team member that assures and measures project performance to defined design control processes.
- Serve as expert in FDA /ISO13485 design control implementation and application to software medical device development processes.
- Serve as expert in development process and assures compliance with FDA development guidance. This includes system requirements definition and system validation, and risk management process including hazard/risk analysis methods and traceability analysis methods.
- Oversee automated design tool validation and developmental document control methods.

Job Requirements:
- Demonstrates strong leadership skills and is a technical expert in quality systems and software medical device development.
- Must be knowledgeable of complex computer controlled systems and design methods for client-server medical record systems
- Leads risk management process applied to each phase of product development
- Ability to perform in a cross-functional development team
- Familiar with Hazops and FMEA and FTA methods applied to software development
- Ability to organize and present technical and process reports without assistance
- Bachelors degree in Computer Science or Electrical Engineering or equivalent
- Training: FDA, 21CFR820 Quality Systems Regulation, ISO13485 Quality System - Medical Devices, ISO 14971 Risk Management

Preferred Experience:
- 5-10 years or more of FDA Class II or III networked-software medical device development experience.
- Experienced in use of contract elements for management and assurance of quality and regulatory responsibilities when contracting elements of product development to outside companies

In addition to great career opportunities, Harvey Nash is proud to offer its valued contract professionals a number of benefits including health insurance and 401(k) matching. Apply now if your skills and experience are a good match for the position and remember this: At Harvey Nash, the door to opportunity is always wide open.df-tc

Experience/Skills
See above

Other desired skills:
Senior Principle Quality Engineer
This job has expired.