Job Description

Medical Quality Engineer, ISO 13485, FMEA, FDA, audits Medical Quality Engineer, ISO 13485, FMEA, FDA, audits, process validation, quality documents Skills Required - ISO 13485, FMEA, FDA regulations, audits, Medical Quality Engineer, quality assurance, product development, process validation, technical writing

Medical Quality Engineer

We are seeking a quality engineer with great experience in a medical or biomedical manufacturing company.

Some of what you will do:

- implement & maintain product quality documents
- lead problem resolution efforts
- assist in training employees on RA & QA procedures
- participate in and lead audits
- assist with new product development efforts
- assist attaining ISO 13485 inspection
- be our go to person about applicable governmental regulations

What you must have:

- 3+ years as a quality engineer with a medical or biomedical manufacturer
- process validation experience in accordance with FDA regulations
- medical quality system experience (ISO 13485 as an example)
- excellent problems solving skills (FMEA, DOE's and K-T)
- solid technical writing skills and interpersonal communication skills

Why work with us?

- we are a stable company that isn't going anywhere
- excellent salary DOE
- generous benefits

So if you a quality engineer with 3+ years of experience in a medical or biomedical manufacturing environment send your Resume immediately!