| 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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