 |
|
|
Quality Engineer and Quality Systems CAPA Specialist, Atlanta and New England. Sept. 16, 2009
Quality Engineer and Quality Systems CAPA Specialist - Medical Device & Biologics
Profitable Medical Device and Biologics company has created a Quality
Engineer and Quality Systems & CAPA Specialist role to lead
investigations and fix some of their challenges they are seeing. This
is a very fast paced company and it sounds like someone strong with
statistical, risk management, Six Sigma or root cause analysis (RCA)
skill will be well situated to succeed here. See more @
www.fpccareers.com
Top Challenges:
You will need to get a good grasp around product design and characteristics so as to:
a. Assess risk and determine if the FMEA or dFMEA should be revised.
b. Lead complaint investigations and perform root cause analysis ( RCA ) up to and including back to the design history.
2) Using Six Sigma DMAIC Methodologies, you will provide leadership
support for product investigations and improvement initiatives to
determine and/or recommend product quality specifications changes. You
will also create and implement programs and processes to ensure product
compliance.
3) Using the input data you obtained from complaints, nonconformances
and trends, apply your conclusions and implement best practices into
CAPA investigations.
4) Writing, review, and approval of site Quality records associated
with investigations including: SOP’s change orders, document
change requests, elevated investigation milestones, and
corrective/preventive action plans
Salary: As there are multiple opportunities at multiple levels and
locations, the base salary will depend on you experience and the level
you achieve. The overall range should be from approx 80 to 100 and will
also include bonus, relocation and benefits.
Location: Atlanta, GA and New England
Contact: Apply @ www.fpccareers.com and/or contact Ira Mann at iram@fpccareers.com
Requirements: See www.fpccareers.com for full posting. Most important is to show your accomplishments with:
1) Using statistical analysis or Six Sigma (especially DMAIC) to
provide leadership support for product investigations and improvement
initiatives and to determine and/or recommend product quality
specifications changes.
2) Leading complaint investigations and performing root cause analysis ( RCA ) up to and including back to the design history.
|
|
|
 |
|
Vendors
Bluequery BI
Software
|
|
|
