QC Inspector

Fremont, CA

Posted: 04/22/2019 Employment Type: Contract Industry: IT Job Number: JOS000008344

This company 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 

You may be just who we are looking for! 

This company is growing! We're looking for a Quality Control Inspector to join our Fremont, CA team! 

As a uniquely qualified candidate, you will: 

* Approve incoming materials / finished goods by performing physical tests to determine if product meets specifications: conduct visual and measurement tests; reject, segregate and report unacceptable materials. 

* Document the inspection results by completing reports and logs; enter data into quality database and verify the CoC. 

* Review Lot History Record to ensure its completeness and correctness. 

* Constant vigilance and implementation of GMP and GDP practices. 

* Assist in the prevention of nonconforming product from being shipped to customers. 

* Identify and record problems relating to product, process, and quality systems. 

* Suggest actions for continual improvement to products, processes or systems and support the implementation of solutions. 

* Communicate with Manufacturing personnel and Engineers regarding quality issues. 

* May perform quality training or any other quality related task – if designated. 

Education and Experience: 

* Minimum 2 – 5 years of applicable experience required. 

* Knowledge and adherence to all Quality procedures. 

* Ability to read and understand drawings. 

* Proficient in using various tools, gages, and measuring devices. 

* Advanced computer literacy (MS-Office required, ERP, ability to learn software programs quickly, etc.). 

* Ability to work alone 

* Ability to train others as needed. 

* Strong attention to details and organized. 

* Able to multitask and deal with multiple requesters at the same time. 

* Experience with Contract Manufacturing, preferably in Medical Device; experience in a clean room environment is preferred. 

* Experience with QC/QA/QE Techniques, Standards and principles. 

* Familiar with Quality conventions (Non-conformance, GAGE R&R, “first article”, SPC, Validation, FMEA etc.). 

* High School Diploma minimum. College work or degree is preferred. 

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