Quality Engineer 2 job Franklin Lakes New Jersey
Quality Engineer 2 job Franklin Lakes New Jersey
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Quality Engineer 2 Job

Employer Name: Mithu Roy SpiderID: 8820056
Location: Franklin Lakes, New Jersey Date Posted: 7/19/2019
Wage: Category: Medical/Health
Job Code:

Job Description:

Hope you are doing well!!!

This is Mithu from Infojini Inc.
We have a position that very closely matches your skill set.
Infojini Inc. is looking for Quality Engineer 2 in Franklin Lakes, NJ with one of our clients PepsiCo this is a 12 Months contract opportunity.

If you are available and interested in the below opportunity, please send me your updated resume along with the rate expectation to mithu.roy@infojiniconsulting.com or you can call me at 702-448-6222. Thanks

Job Title: Quality Engineer 2
Location: Franklin Lakes, NJ
Duration: 6 months Contract
Rate: Open

Job Description:
Individual with thorough experience in quality engineering, quality systems, validation, risk management and design control for a market leader in the medical device industry.

Summary of Skills:
Extensive knowledge of quality engineering, and or quality systems for medical devices and Design Controls
In-depth knowledge of the concepts of; design control, engineering change control, statistical techniques, verification and validation methods/protocols, risk management, design history files (DHF), device history and master records (DHR/DMR), CAPA, 510(k) etc.
Well-versed in the methodologies of verification and validation for medical devices
Sound knowledge of FDA Quality System Regulations; 21 CFR Part 210, 211, especially 21 CFR Part 820 etc.
Sound knowledge of ISO13485 for medical devices
Quality engineering concepts such as; statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, engineering change notices etc.
Audit experience a plus
Knowledge of basic computer applications, Microsoft suite of tools (Word, Excel, Power Point etc.), Minitab for statistical analysis, SAP, Trackwise a plus
Can communicate effectively
Must be able to work under minimal supervision on somewhat ambiguous tasks

Work Experience
Medical Device Quality Engineer/Quality Systems Engineer/Quality Auditor
About three (3) to five (5) plus years of experience within FDA regulated medical device and or pharmaceutical industry with knowledge of FDA and ISO regulations

Education and Certifications
Bachelor's Degree in a scientific discipline
ASQ CQE, CQA, Six Sigma certification a plus

Additional Job Description
Assist in special assignment to assess FDA regulatory gap analyses
Assist in special assignment to assess compliance to the new European MDR requirements

Work authorization in US: (Citizen/GC/EAD):
Best phone # to reach you:
Alternate number to reach you:
How soon can you join the new position?
Do you have any offers in pipeline or are there any companies you are currently interviewing with? (Y/N)

*Please attach your updated resume along with your answers*
*Please feel free to forward this email to any friends or colleagues that may be interested in this position.
*Note: This is not an automated e-mail, please reply to mithu.roy@infojiniconsulting.com

Job Criteria:
Start Date:
Position Type: Contractor
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:

Contact Information:
Contact Name: Mithu Roy Company Type: Staffing Agency
Company: Infojini Inc Phone: 702-448-6222
Street: Fax: 443-283-4249
City: Baltimore
State: Maryland

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