Medical Device Manufacturer seeks QA/QC individual for varied self-driven tasks:
- Machined/Mechanical parts inspection.
- Finished goods product inspection.
- Incoming parts and raw material inspection.
- Product Verification to Engineering specification.
- In-process assembly inspection.
- Write inspection procedures for products.
- Ensure compliance with FDA regulations.
- Work with regulatory affairs to implement a new quality system.
Must have 2 years or more experience in the following:
- Optical comparators.
- Coordinate measuring machines (CMM) and software.
- Use of various micrometers, digital and analog.
- Use of calipers, digital and analog.
- An understanding of medical device regulations.
- Familiarity with ISO and CE regulatory requirements.
- Regulatory affairs knowledge and/or experience helpful, but not required.
With international headquarters in Rancho Cordova, California, OrthoGroup, Inc. is an innovator and leading designer in the manufacture and global distribution of devices for the medical industry. Since its founding in 2003, OrthoGroup, Inc. is committed to quality medical device design and manufacture, use of innovative technologies and unsurpassed customer satisfaction.