Change from Automotive to Medical Device Industry

[manojs1234]

Hello,

I have been working as a quality engineer with a Tier 1 automotive supplier for the past 7 years and I am thinking of making a career switch to medical industry. I recently got my ASQ CQE certification I know that most of the medical device manufacturers ask for it. I also know that most of the medical companies don't prefer engineers with an automotive background and that's my biggest obstacle. Can anyone please tell me what kind of details a medical device company wants to see in my resume so as to get their attention. Any help in this matter is highly appreciated.

Thanks

Manoj

[Duke Okes]

Experience working with regulations (legal requirements for which lack of compliance can result in lawsuits, jail time, put out of business by FDA) vs. standards (voluntary requirements or requirements imposed by customers for which lack of compliance can result in screaming, loss business to a single customer). Example: 21 CFR Part 820

[DannyK]

Experience with ISO 13485, CE Marking, 21 CFR820, Canadian Requirements are usually required.
Internal auditing skills are very important.
In some respects, the automotive standards are more demanding than medical devices.
Knowledge of FMEA and Risk management are also important.

I would recommend that you scan the job ads and see what the typical job requirements are.

[manojs1234]

Thanks Danny for your recommendation