Quality Assurance Specialist

IL, IL Full Time

POSTED ON 2/23/2024

Job Posting for Quality Assurance Specialist at Novozen Healthcare LLC

Role : Quality Assurance Specialist

Location : Des Plaines, Illinois,

Duration : 12 Months on W2

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 and 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.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Lead complaint investigations on returned products and Manage corrective action and quality improvement activities.
Manage aspects of the internal quality system relating to receiving inspection, calibration, MRB, etc.
Assist in the performance of quality system internal auditing and support quarterly management review meetings.
Investigations Experience : Design Investigation or Failure Investigation - CAPAs, CMRs, DIRs

Education and Experience :

Master’s or Bachelor's required (Mechanical, Industrial, Biomedical, chemistry or any related Engineering) with min of 2 to 4 years’ experience

3 days ago

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