Quality Engineer - Scarborough, United States - The Fountain Group

Description

The Fountain Group is currently seeking a

Line Quality Engineer

for a prominent client of ours. This position is located in

Scarborough, ME

Details for the position are as follows:


Payrate:
$44/hr W2


Job Title:
Line Quality Engineer


Location:
Scarborough, ME

Duration: 7 months contract.

8am - 5pm; Monday - Friday.

Mandatory
HS Diploma (but must have job experience)
Prefer bachelors or associate degree.
Must have some experience in quality environment.
Looking for experience with batch records, SOPs, structured documentation
Must be an excellent communicator and extremely organized.
Must be familiar with Excel.


Job Description:
The purpose of this position is to initiate medical device quality assurance activities.
These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards.
This position will also support device complaint investigation and failure analysis as required.


Essential Duties and Responsibilities:
Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review.
Complete final acceptance activities.
Manage the sterilization process, including validations and product sterile loads.
Track nonconforming material and lead Material Review Board (MRB) efforts.

Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.

Lead complaint investigations on returned product.
Manage corrective action and quality improvement activities.
Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
Assist in the performance of quality system internal auditing.
Support quarterly management review meetings.
Establish, monitor and evaluate quality system metrics.

This team does new product introduction.
We need someone with a lot of familiarity of the quality management system (Agile)
They should be a very quick learner of systems if they do not know Agile.
This person will not be out on the line, needs to be quality minded.

They need to be able to understand quality systems, work with teams who have documentation routing through the system and be able to summarize the activities.

The goal is to drive to the approvals of each activity.

The system has a lot of various steps - the worker will get into the system and understand it and clearly outline the next steps to have progress made.

i.e., Do I need to reach out to an owner to collect a document, i.e., to drive closure on quality documents?.

If you are interested in hearing more about the position please respond to this posting with your resume attached or contact me at

Please forward this email to any friends or colleagues as we do offer a

Referral Bonus

for any candidate who is hired and still gainfully employed after 30 days.
#J-18808-Ljbffr