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ISO 13485 Assessment / Auditing. CAPA Planning and Implementation. Change Control System Management. EDMR Implementation and Control. System Control and Monitoring (VSM).

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ISO 13485 Assessment / Auditing. CAPA Planning and Implementation. Change Control System Management. EDMR Implementation and Control. System Control and Monitoring (VSM).
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2 references
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4 testimony
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7 quality engineering
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ISO 13485 Assessment / Auditing. CAPA Planning and Implementation. Change Control System Management. EDMR Implementation and Control. System Control and Monitoring (VSM).

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1

Staff

http://www.sigma-sos.com/staff.html

Validation - Engineering - Lean Six Sigma - Regulatory. 2003 2013 Medtronic Sofamor Danek (Medtronic HQ: Memphis, Tennessee). Principal Supplier Development Engineer (2008 - 2013). Principal Instrument Manufacturing Engineer (2005 - 2008). Product Development Engineering Technician (2003 - 2005). 1995 2000 Sofamor Danek (Warsaw, Indiana). Senior Manufacturing CAD Engineer Manufacturing Engineering (1996 2000). 2000 2003 Integra Medical Technologies Warsaw, Indiana. Education / Professional Development.

2

Engineering

http://www.sigma-sos.com/validation-and-engineering.html

Sigma (SOS) is that one stop service to provide all your validation and engineering needs from a specific area of need to a full turnkey project including product introduction, machine selection, qualification, process development, inspection, validation and then to SPC for reduced inspection during production. Below listed is the specific areas of support that we provide. Complete all open validations and qualifications and standardize one complete system to prevent duplication of work. Provide assistan...

3

Regulatory

http://www.sigma-sos.com/regulatory.html

Key system areas of support include:. Supplier Performance and Monitoring.

4

Lean Six Sigma

http://www.sigma-sos.com/lean-six-sigma.html

In our business of medical device manufacturing we make setups and this area of lean has the highest impact on profit or loss. How do we implement not only SMED but create a culture of continuous improvement for lean manufacturing? SMED - Single Minute Exchange of Die. Below is the steps of the SMED improvement process. Determine Set-up Time Reduction Goal. Identify Internal vs. External Elements. Shift Internal to External. Execute and Test New Methods. Analyze New Method and Videotape. Select an accred...

5

Testimony

http://www.sigma-sos.com/testimony.html

For even the Son of Man did not come to be served, but to serve, and to give his life as a ransom for many.".

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