Quality Control Inspector III

Confluent Medical Technologies•Fremont, CA

3d•$23 - $38•Onsite

About The Position

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers. We are looking for a Quality Control Inspector III to join our Fremont, CA team for a 8:30am-5:00pm shift.

Requirements

High School diploma with minimum 7 years’ experience in medical device or FDA regulated industry.
Ability to read engineering drawings and understand inspection requirements.
Good written and verbal communication skills.
Knowledge of International Standards (ISO) and FDA Regulations for Medical Industry
Knowledge of good manufacturing principles (GMP & GDP)
Attention to detail, professional attitude, team player.

Nice To Haves

Experience with a medical device firm (or sub-contractor) with clean room environment inspection preferred.
Experience with inspection, including measurement tools, interpreting engineering drawings preferred.

Responsibilities

Performs final inspection of raw material per procedures
Performs in-process and final inspection for medical components/material per procedures to certify quality and adherence to specifications
Performs inspections and final checks
Records inspection and test results per procedures.
Data entry in database as required. Working knowledge of Excel preferred.
Position interacts with various development departments and requires individual to be supportive, cooperative and an effective communicator.
Complies with all Quality System policies and procedures.
Performs other tasks as assigned by Supervisor/Manager.
Coordinate and control that product and product process changes documented through the product/process change system are validated according to the established requirements per Design and Change Control systems.
Supports OC training / filing of employee training records.
Support appropriate parties during internal and external customer and regulatory audits.