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Location

Pompano Beach, FL | United States

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Job description

If you are a QA Engineer with experience, please read on!

Headquarters in beautiful Pompano Beach, FL (a stone's throw from the white sand & green water!) Role is Hybrid from South, FL!

We are an innovative and first-of-it's-kind Medical Device Manufacturer with the first FDA approved non-toxic pain management system that offers a critical alternative to the Opioid crisis! Our device is implanted into the patient thru a minimally invasive 20 min procedure, and then they can control the amount of pain relief they receive thru their smart device - it's that simple. Do you want to help people get access to this product asap? Apply now. We are rapidly growing!

Top Reasons to Work with Us

- First of its kind Non Toxic Pain Management Product

What You Will Be Doing

- Complaint Handling
- FDA MDR (adverse event reporting)
- NCMRs
- MAUDE
- Medical Device Reporting

What You Need for this Position

- at least 3-5+ years of professional experience
- BS in BioMed OR related engineering field
- experience with Complaint Documentation
- experience with CAPAs + CFR 21.803 (or related)
- experience with Medical Device Reporting (MDRs)
- experience with ISO standards + cGMP

Bonus Points:
- experience with BioMed
- experience with with FDA
- experience with EU, Japan, Brazil, Canada OR related MDR (medical device regulations)

What's In It for You

- Regular Company Functions / Lunches / Stocked Kitchen!
- Vacation/PTO!
- Full Benefits: Medical, Dental, Vision!
- Amazing Work Environment!
- HUGE room for growth (lucrative startup)!
- A team of sharp people on the same mission!
- Must be authorized to work in the US without Sponsorship

So, if you are a QA Engineer with experience, please apply today!

Applicants must be authorized to work in the U.S.

Preferred Skills

CAPA

CFR 21

CFR

Complaint Documentation

Device Reporting

Clinical Database

Complaint

remediation

Audits

Internal Audits

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Job tags

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Salary

$90k - $125k