Hi,
Hope you are doing well !!
My name is Harish Karnala and I am a
technical recruiter with United Software group. I reviewed your information
online and I am impressed with your qualifications. One of my clients in
the * below mentioned *area currently has a Staff Quality Engineer, CAPA
and NCR role that they are looking to fill. Here are the details on the
role:
*JD:*
*Job Title*
Staff Quality Engineer, CAPA and NCR
*Relevant Experience *
*(in Yrs)*
BS in a Chemistry, Biology, or Engineering discipline with 5 — 8 years of
related CAPA and NCR Management experience. Minimum of 2-3 years'
experience in the medical device industry is required.
*Technical/Functional Skills*
· Must possess a clear understanding of theoretical and practical
fundamentals and experimental engineering techniques. Good written and oral
communication skills. Computer literate.
· Ability to use broad knowledge of regulatory, technical, and
business requirements to effectively lead and manage improvement projects
for Quality Systems for Biosense Webster.
· Ability to apply project management skills to measure and improve
performance in areas of responsibility.
· Thorough knowledge of CAPA and NCR.
· Demonstrated root cause and problem solving skills.
· Ability to apply Six Sigma and Process Excellence tools and
methodologies.
· Demonstrated verbal and written communication skills, and ability
to effectively communicate with internal and external personnel.
· Ability to effectively train and influence a diverse array of
employees impacted by Quality Systems initiatives and performance
measurements.
· Business and financial acumen.
The qualified candidate for this hands-on position should be able to use
Engineering principles, tools, and practices to determine root cause of
component failure and develop and implement the changes. The individual
must be capable of working independently and in a team setting supporting
the resolution of component failures and conducting required statistical
analysis.
*Experience Required*
5-8 years
*Roles & Responsibilities*
The primary responsibilities of this role include
· Responsible for implementing, revising, executing, and maintaining
CAPA and NCR procedures across the CSS companies.
· Responsible for communicating quality and business-related issues
or opportunities to next management level
· Chair CAPA Review Board, meeting minutes from CRB meetings
including action items. Follows up on all action items until all items are
completed and closed.
· Track and provide monthly CAPA and NCR Quality Performance Metrics
· Responsible for communicating business related issues or
opportunities to next management level
· Responsible for ensuring subordinates follow all Company
guidelines related to Health, Safety and Environmental practices and that
all resources needed to do so are available and in good condition
· Responsible for ensuring personal and Company compliance with all
Federal, State, local and Company regulations, policies, and procedures
· Performs other duties assigned as needed
*Education*
BS in a Chemistry, Biology, or Engineering discipline with 5 — 8 years of
related CAPA and NCR Management experience. Minimum of 2-3 years'
experience in the medical device industry is required.
*Duration of assignment *(in Months)
06 months
*Work Location* (State, City and Zip)
Irwindale, CA (25-50%) and Palm Harbor, FL (50-75%)
*Travel*: This position travels frequently, up to 50% and should be
prepared for extended stay when required
Harish Karnala
United Software Group Inc..
565 Metro Place South. Suite # 110
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g>
Dublin, OH 43017
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g>
Direct Number : +1 614-408 1549
Board Number : 614-495-9222 EXT. 622
Fax: 1-866-764-1148
karnal...@usgrpinc.com
www.usgrpinc.com
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