Minimum requirements/experience/qualifications to be head of quality

Dr RA

Involved In Discussions
#1
What are essential minimum requirements/ experience/ qualification to be head of quality : MDD/ISO 13485 company
 
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M

MantleMickey

#2
I have had the title of QA/Regulatory Mgr. since 1998.
They need to know G D & T, blueprint reading, ISO 13485,
which is the medical device reg, or 9001 for general reg.
Good investigation skills, ie corrective action skills, ability
to read hand gages, optical comparators.
Communication skills are essential, working with production
and quality personnel, conflict resolution skills are desireable.
Time management, as you will be pulled several directions, must keep
your cool.
This is just a short sample, I am sure others will also input their answers
as well.
Good Luck!
 

Ajit Basrur

Staff member
Admin
#3
What are essential minimum requirements/ experience/ qualification to be head of quality : MDD/ISO 13485 company
Could you be more specific if the position is a Quality Manager of a manufacturing plant or like a Vice President as head of quality ?
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
you need to be far more specific as to class and type of device.
The the scope of knowledge for the head of quality for a maker of injection molded syringe barrels and plungers will be very different from the head of quality for the manufacturer of a pacemaker.
 
M

MantleMickey

#5
Sorry, I have worked in 2 different areas--plastic injection molding, and machining of UHMW Poly for knee and hip replacements, as well as class 10,000 cleanroom. Now I work for a totally different company, metal diamond cutting burs. Both were and are manufacturing plants, and I was 25% quality manager, with a lot of my time on ISO 13485 and ISO 9001.
 

planB

Trusted Information Resource
#6
Concurring with the previous posters: it's up to the individual company to define the required job profile of a "Head of Quality"
 

Dr RA

Involved In Discussions
#7
The devices go up to IIb manufacturing and the current problem is : do we need the head of Quality to have experience in the area on QA/RA of MDD/IVD and 13485? Or if there is a staff with knowledge of these criteria, can this be justified?
 
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