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Reference Number:
jobs
Job Description:
you must have medical device experience for this jobs
Warm Regards, (ciao)
Joe
Joseph Anthony Vaccariello
7 days a week
joseph8601@sbcglobal.net
http://www.linkedin.com/pub/3/945/77
Experience Level:
3 Years
Requirements:
QUALITY ENGINEER, great bennies, 70K
Fairfield County, off Metro North
QA Engineer with an electro-mechanical background for our "capitol" equipment line
Manufacturing "process control" experienced who can look at a work cell for a product. They would look at the start to finish for the assembly - i.e.. starting at incoming QC to assembly by method sheets to final test/release and look for data that could be collected to help improve the assembly process and especially the quality of the product. They would also help with method sheets, if they need fixed, or tests that need revised in the work cell or additional fixtures that need added or revised. We want to get more "data" and information from our processes that will impact the product quality. This will lead to improvements by our material suppliers [or replacements of suppliers, if necessary], better manufacturing processes that will give us quality trends so problems can be identified before the customer ever sees the product and/or improved in-process & final tests to assure the product meets spec. before it goes out to distribution.
This is not really "lean" manufacturing, but someone who can improve our overall product quality, so it is more of a quality engineering position. The goal here is zero defects at the customer.
The best fit would be a person with a background in manufacturing engineering and a quality"process" background. As we have a number of expensive capitol equipment products that have electronics associated with them, that is why I really want someone familiar with PCBs, electronics and electromechanical medical equipment.
POSITION SUMMARY: PROVIDE WRITTEN AND VERIFIED ASSURANCE FOR PRODUCT PROCESS VALIDATION THROUGH CREATION OF MAINTANIENCE PROTOCOLS.
FUNCTIONS:
1-VALIDATE EXISTING AND NEW PRODUCTS THROUGH CONCEPT DESIGN DEVELOPMENT AND TRANSFER TO MANUFACTURING OPERATIONS REQUIREMENTS
2-DEVELOP PROCESS VERIFICATION CONTROLS USING ROOT CAUSE ANALYSIS TECHNIQUES.
3-CREATE AND MAINTAIN DATA ANALYSIS FOR STATISTICAL PROCESS CONTROL MONATERS
4-UTILIZE EXTERNAL STANDARDS FOR AGREEMENT WITH COMPANY PROCEDURES AND REGULATORY COMPLIANCE
5-INVESTIGATE FEEDBACK FROM THE MARKET PLACE AND FACILITATE RESPONSE TO THE PRODUCT ANALYST AND PRODUCT MANAGEMENT
6-DIRECT PROBLEM SOLVING
7-PROVIDE LEADERSHIP FOR VERIFICATION/VALIDATION OF PRODUCT, PROCESS AND EQUIPMENT INSTALLATION/ QUALIFICATION/PROCESS INTEGRATION (IQ/QQ/PQ)
8-CONDUCT RISK MANAGEMENT FROM INITIAL DESIGN FORWARD TO TECHNICAL REVIEW
QUALIFICATIONS:
TECHNICAL/INDUSTRIAL EXPERIENCE IN QUALITY ENGINEERING OF MEDICAL DEVICES
DEGREE IN MECHANICAL, ELECTRICAL OR CHEM ENGINEERING
COMPUTER PROFICIENCY WITH STATISTICAL PROCESS STRATEGIES
RELATED EXPERIENCE IN DESIGN OF EXPERIMENTATION
EXCELLENT VERBAL/WRITTEN COMMUNICATION SKILLS
QUALITY BUSINESS SYSTEM KNOWLEDGE.
There is no one out there with all these qualifications, this is a "wish list".
Basically, we need a QA Engineer with an electro-mechanical background for our "capitol" equipment line . Software experience is a plus.
We found a QA Engineer for the disposable line, but not capitol- yet.
We are - in fact - looking for a Quality Engineering here if you know anyone. Here is a list of what proposed:
Any and all of these traits and experiences in "Electromechanical Bio-Medical Instrumentation" will be needed - in no particular order mind you:
1. Electrical Engineering
2. Mechanical Engineering
3. Software
4. Firmware
5. Design of Experiment
6. Trouble Shooting
7. Underwriters' Laboratory Compliance
8. IEC 60601 Standards Compliance
9. Data Collection
10. Document Control Software experience
11. OSHA Familiarity
12. Ergonomics
13. Fiber Optical experience
14. Passivation
15. ESD
16. Method Sheets
17. Contribute to Manual Review
18. Ship/Drop Testing
19. We'll listen to all ...
Understand the candidate will likely not have all of the above.
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