Quality Engineer

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Job Posted on January 30, 2008

Quality Engineer

Company	:	Eagle Employment
Company URL	:	http://
Contact Name	:	Faleshia Pines
Position Type	:	Contract-3 Months
Salary	:	Negotiable
Experience	:	4-6 years
City	:	Danvers
State	:	MA
Country	:	USA
Zip	:	01923
Contact	:	Faleshia Pines, Employment Specialist Eagle Employment 1113 East Franklin Avenue, Suite 200 Minneapolis, MN 55404 Local:612.877.7000 ext 1043 Toll Free:1.877-703.2453 ext 1043 faleshia@eagleemployment.com
Description	:	Provide comprehensive support to a product development team and Quality Assurance Department in all areas of pre-production quality assurance and design control Actively participate in definition of test requirements, justification of acceptance limits and sampling plans to assure compliance with Vascular, corporate, FDA and international requirements Provide complete, accurate and efficient documented quality plans for each assigned product sampling points and plans, process control requirements, certified test methods and functional evaluation criteria at all stages throughout product life Perform product and process evaluations to identify areas for improvement Recommend solutions to identified problems. Implement approved changes using sound quality engineering principles and fully document them in compliance QBS, GMP and international requirements on a timely basis Mentor or Supervise Quality Engineers or Technicians Assist Regulatory Affairs and Engineering personnel in new product/process design to assure effective control procedures are established Participate actively in product and process start-ups. Design and write protocol and implement process validation procedures in accordance with QBS, FDA and international guidelines Routinely review regular inspection data and prepare statistical and operational performance reports including Total Quality Cost Reports. Analyze defect conditions and defective material as necessary to implement corrective actions Perform process capability studies and design experiments and special studies necessary to increase control and lower total quality costs Participate in or lead Lean Sigma projects Perform day-to-day troubleshooting and resolve immediate problems on the floor. Act as QA representative on MRB (Material Review Board) and in the documentation approval process for assigned products Participate in meeting departmental goals and objectives. Participate in cross-functional or departmental team projects Perform all responsibilities with the achievement of Customer-Focused Quality as the primary priority and goal
Experience	:	QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC Compliance Bachelor’s degree in engineering discipline Must have a higher level of understanding for the FDA and ISO13485 regulations Must be able to understand and lead Risk Analysis Teams Demonstrated working knowledge of process validation, design of experiments, vendor and internal auditing, statistical quality control, biocompatibility, protocol/report preparation and material review board Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 PREFERRED EXPERIENCE (not required) ASQ certification. Six Sigma greenbelt or blackbelt certification Minimum five years quality assurance experience in a GMP environment or highly regulated industry. 3-6 years with a Masters of Science. 6-10 years quality assurance experience in a QSR (GMP), disposable medical device environment. Guide wire/guide catheter experience

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