Change of fields - Quality Engineering Electronics Vs medical Devices

QE

Quite Involved in Discussions
#1
Hello Dear Coves

I am considering a change from being a Quality Engineer from a Documentation heavy medical devices to a more technology oriented Hitech industry may be a consumer electronics or something which is less regulated and more towards core quality engineering and reliability disciplines.

Can folks from those industry advise on pros vs cons of being in to these settings. whether it is a good idea or not and help me with a strategy on how to attempt this activity ?

Thanks QE !!!
:thanks:
 
Elsmar Forum Sponsor
S

silentrunning

#2
I will give you my perspective on this since you asked. I have been with the same manufacturing company for 40 years and have seen MANY tech companies come and go. When I started here one of our big customers was IBM and we made parts for typewriters. Millions of parts. We also made aluminum cases for police radios. Now all that product is gone. We are constantly having to upgrade our knowledge, skills and machinery. Going into manufacturing in the United States today is a **** shoot at best. The medical industry however is here to stay. It is highly regulated and competitive but it isn?t going away. If I were just starting out I would get INTO the medical products field, not out. I know there will be some that disagree with my analysis but that?s the way I see it.
 

QE

Quite Involved in Discussions
#3
Doug,

Thanks for replying. But after you stay in medical devices for a while, you realize that the amount of **** - documentation is very high.

Thanks for your thoughts.
I appreciate it.
 

normzone

Trusted Information Resource
#4
Well, balance the challenges of what you're doing now, which is probably as well controlled as it can be, vs the chaotic churn of the commercial products world. If you are a chaos junkie you will thrive in the consumer / commercial environment.

But depending on your temperment and tolerance for disorder you may find yourself yearning for the old days of stability and control - have you taken any of the personality profile tests? QA in this game makes herding cats look easy.
 

QE

Quite Involved in Discussions
#5
Well, balance the challenges of what you're doing now, which is probably as well controlled as it can be, vs the chaotic churn of the commercial products world. If you are a chaos junkie you will thrive in the consumer / commercial environment.

But depending on your temperment and tolerance for disorder you may find yourself yearning for the old days of stability and control - have you taken any of the personality profile tests? QA in this game makes herding cats look easy.
Hello normzone,

Thanks for your insight and thoughts. No I have not taken any personality tests and will appreciate if you can advise a website where to take one.

Nirlep Sanghvi
 

normzone

Trusted Information Resource
#6
I don't know of any, I'll look around. All the employees at my previous company took a personality profile test several years ago - I test out as extremely forthright (I'll tell everybody how I REALLY feel) and I'm highly tolerant of disorder.

My engineering staff was shocked to learn this (we all shared our results) and were concerned that this was not an ideal temperment for a QA guy. I responded with " Somebody with a low tolerance for disorder would crack if they had to work with this group ". They were not impressed, but it was true.
 

QE

Quite Involved in Discussions
#7
I don't know of any, I'll look around. All the employees at my previous company took a personality profile test several years ago - I test out as extremely forthright (I'll tell everybody how I REALLY feel) and I'm highly tolerant of disorder.

My engineering staff was shocked to learn this (we all shared our results) and were concerned that this was not an ideal temperment for a QA guy. I responded with " Somebody with a low tolerance for disorder would crack if they had to work with this group ". They were not impressed, but it was true.
Please let me know, I will definitely like to take one and see where I stand.
 

normzone

Trusted Information Resource
#8
Do a google search for Meyers Briggs. The really exhaustive tests usually want some money, there's some short version tests that are free. The test results come in different formats depending on who the test authors were, and how they define various personality types.
 

sagai

Quite Involved in Discussions
#9
The amount of rigmarole that people erect in medical device companies is predominantly up to them rather than real regulatory needs.
Cheers!
 

QE

Quite Involved in Discussions
#10
The amount of rigmarole that people erect in medical device companies is predominantly up to them rather than real regulatory needs.
Cheers!
True, but those decisions are made by the management. The QEs are the scape goats in the process. No one respects and No one cares either.....Ultimately they are going to keep shipping the products and make money and put it in their deep pockets.
 
Thread starter Similar threads Forum Replies Date
Q Change of fields within Quality Career and Occupation Discussions 4
qualprod What do CB´s change when doing a partial moving ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Y Algo change significancy Medical Information Technology, Medical Software and Health Informatics 0
Revision36 Engineering Change Order Industry Standards Other Medical Device and Orthopedic Related Topics 4
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 2
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
Q Change the shape of the raw material FAI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Engineering Change Order (ECO) metrics to track ISO 13485:2016 - Medical Device Quality Management Systems 6
P Notified Body Approval of Change EU Medical Device Regulations 2
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
J FDA notification of address change US Food and Drug Administration (FDA) 2
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3
R Change Management vs Opportunity for Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 1
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Marc Insects and Climate Change - 2020 World News 0
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N China - Start manufacturing before change approval? China Medical Device Regulations 1
L 510K - Trade Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
K Is a change that fixes a recalled device significant? Medical Device and FDA Regulations and Standards News 2
L Significant change notice for outsourced warehouse Medical Device and FDA Regulations and Standards News 2
U Change Management vs Change Control? Design and Development of Products and Processes 4
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
P Change on Medical Device Classifications - Dental Crowns Other Medical Device Regulations World-Wide 2
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5

Similar threads

Top Bottom