Elsmar Cove Forum Header Graphic The Elsmar Cove Wiki Sitemap More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar Cove Forums Main Page Elsmar Cove Home Page
NQA-USA
Miner's MSA (Measurement Systems Analysis) Blog 
Go Back   The Elsmar Cove Forum > Professional Employment and Occupation Related > Career and Occupation Discussions
Forum Username

Wooden Line

Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!


Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links

Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
fda (food and drug administration), iso 13485 - medical device qms
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 16th June 2008, 02:33 AM
confusedkid

 
 
Total Posts: 3
Thank You! Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!

Hi Everyone. My company is divided into two sections: (1) a medical device manufacturing company exclusively for the (2) CLIA certified clinical lab. My company is not FDA reg or ISO certified and we are striving to obtain certification but I fear it won't be completed for awhile. We have some systems in place but not all. I've been here for 3 years. I have a total of 4 years of experience in quality and I've taken ISO 13485 training classes. If I look for another job, will it hurt me that my company is not FDA/ISO regulated? What can I write in my resume? Thanks!

Sponsored Links
  Post Number #2  
Old 16th June 2008, 09:32 AM
Wes Bucey's Avatar
Wes Bucey

 
 
Total Posts: 11,002
Re: Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!

Quote:
In Reply to Parent Post by confusedkid View Post

Hi Everyone. My company is divided into two sections: (1) a medical device manufacturing company exclusively for the (2) CLIA certified clinical lab. My company is not FDA reg or ISO certified and we are striving to obtain certification but I fear it won't be completed for awhile. We have some systems in place but not all. I've been here for 3 years. I have a total of 4 years of experience in quality and I've taken ISO 13485 training classes. If I look for another job, will it hurt me that my company is not FDA/ISO regulated? What can I write in my resume? Thanks!
I'm confused. Aren't ALL medical device companies subject to FDA regulation, either directly, or as a supplier to an FDA-regulated company?

In answer to your direct question- the primary question in a new employer's mind will be, "What can you do for us?"

Therefore, you will stress your skills and knowledge and how they will apply to the new employer [I presume you mean an employer who is registered with either or both FDA and ISO.] If you are not currently dealing with FDA or ISO Standards, you will need to show you are at least familiar with them and how your other work experience in dealing with documentation and paperwork will give you a leg up on dealing with the FDA and ISO prescribed documentation without messing up.

Last edited by Wes Bucey; 16th June 2008 at 09:33 AM. Reason: fix typos
Thanks to Wes Bucey for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 16th June 2008, 10:45 AM
BradM's Avatar
BradM

 
 
Total Posts: 5,756
Re: Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!

Welcome to the Cove!

Basically I am in agreement with Wes. Focus on what you do know and what you have accomplished. For all you know, you may have been performing highly valuable services where you were. Just sell who you are; that's what the potential employer is interested in.
Thanks to BradM for your informative Post and/or Attachment!
  Post Number #4  
Old 16th June 2008, 09:05 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,757
Re: Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!

Just to add on the valuable comments so far, it doesnt matter if your organization is FDA certified or not but is very important if you are aware with the FDA or ISO requirements.

During the interview, if you are asked questions on FDA / ISO and you are able to answer those, thats what the prospective employer would be looking for, isnt it ?
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #5  
Old 17th June 2008, 10:20 AM
confusedkid

 
 
Total Posts: 3
Re: Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!

Our medical device is still in developmental stages and isn't sold to anyone in the market. The device goes straight to our clinical lab for their use only. I was told that as long as the device stays internally, we don't have to be FDA/ISO yet.

I'm definitely familiar with ISO/FDA regulations. I'm just worried that I may have developed bad habits and poor implementation of ISO/FDA at my current company.
Thank you to everyone for the advice. It is very much appreciated.
  Post Number #6  
Old 17th June 2008, 10:29 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,757
Re: Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!

Quote:
In Reply to Parent Post by confusedkid View Post

Our medical device is still in developmental stages and isn't sold to anyone in the market. The device goes straight to our clinical lab for their use only. I was told that as long as the device stays internally, we don't have to be FDA/ISO yet.
Thats true

Quote:
In Reply to Parent Post by confusedkid View Post

I'm definitely familiar with ISO/FDA regulations. I'm just worried that I may have developed bad habits and poor implementation of ISO/FDA at my current company.
Thank you to everyone for the advice. It is very much appreciated.
Do not get distracted; stay focussed and always be aligned with FDA / ISO regulations
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #7  
Old 17th June 2008, 11:17 AM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,077
Re: Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!

Quote:
In Reply to Parent Post by confusedkid View Post

I'm definitely familiar with ISO/FDA regulations. I'm just worried that I may have developed bad habits and poor implementation of ISO/FDA at my current company.
In addition to the good advice so far, which boils down to "accentuate the positive," you could run into trouble getting hired without having actual experience in dealing with third-party audits. It depends on the job requirements and how well you might fit the profile otherwise.
Thanks to Jim Wynne for your informative Post and/or Attachment!
  Post Number #8  
Old 26th June 2008, 06:38 PM
capriceblack

 
 
Total Posts: 1
Re: Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!

Hi Confused Kid,

I would like an opportunity to speak with you. I am currently with a small medical device company that is in a similar situation as your current employer. They are looking for a quality manager to lead them through ISO and FDA certification process. You can reach me by email or phone # in the profile.

Thank you.
Caprice Black
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Professional Employment and Occupation Related > Career and Occupation Discussions

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
FDA 510(k) required? US company Private Labeling an FDA Class II Device senna 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 21 10th April 2014 05:45 PM
Advantages of ISO 13485 or 9001 Certification for FDA Approved and Regulated site v9991 ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 3 12th January 2011 10:28 PM
FDA vs. ISO 13485 - Are FDA Documents for Devices accepted in Europe TamTom ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 3 10th January 2011 10:36 AM
Has anyone used ExtraView software in FDA regulated industry? DeviceMaker Qualification and Validation (including 21 CFR Part 11) 3 30th November 2009 12:56 PM
Warehouse Design Layout - FDA Regulated Medical Manufacturer LGDeneault Design and Development of Products and Processes 3 10th March 2006 03:56 AM



The time now is 04:38 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".
no new posts