New Product Development

Add a headcount to boost resourcing on a techncial problem.  I will work within your Design Control system on concepts, prototypes, materials evaluation, design-for-assembly, human factors tradeoffs... 

Jidoka & Pre-Lean Culture

Complete a transfer-to-manufacturing built on solid Quality principles. I can help with groundwork to achieve process excellence (standards, flow, embedded test, make hypotheses, seek the ideal...).

ISO13485
QMS Design

Save us all time by putting together better systems. Begin with each "shall"; it can all be better than many believe.

ISO14971 Risk
Management

Save us even more time when you set high expectations for integrating risk management.  This is not just a few FMEAs.

Measurement and Analysis

Specify and qualify your monitoring technology.  I use JMP's Measurement System Analysis to qualify key elements in your Quality Plan.

Process Validation

Farm out any needed process characterization DOE, equipment specifications, your installation qualification, or the associated OQ/PQ.

Transfer to
Contract Mfg

I can help the customer understand the contractor or the other way around.  Good prints make good partners.

Writing for
Regulatory

Will develop technical documentation as assigned by plan with clearly written conclusions (and when necessary, deviations).

Project Management

With more remote workers and the Great Resignation, I can fill staffing gaps to keep your top project on its schedule.  I can use your documentation tools or bring my own.

Meeting
Facilitation

Some meetings are best handled by independent facilitators with minimal professional skin in the game and good whiteboard skills.  Brainstorms, Root cause, CAPA strategy...

QMS Auditing

Due Diligence

Mentoring 

Team Training