X-spine Systems, Inc. is a global developer, manufacturer and marketer of implants and instruments for use in surgery of the spine. We are committed to the highest standards of product quality in service of the patient and physician.
This is an excellent opportunity at our headquarters in the South suburbs of Dayton, Ohio. Candidates must possess the following education, skills and abilities:
- Bachelor’s degree in Science or Engineering
- 3+ years related experience in quality control and dimensional inspection, preferably with medical devices
- Knowledge of FDA 21 CFR Part 820 requirements and understanding of ISO 13485 Quality Management Systems
- Must have a strong knowledge of geometric dimensioning & tolerancing and the application of ASME Y14.5 to dimensional inspection.
- Preferred qualification include: an understanding of Orthopedics materials and manufacturing processes, and ASQ Certification as Quality Engineer
Responsibilities for this role include:
- Ensure that the proper resources are identified and implemented for the first article, receiving and final inspection activities
- Design inspection tools (e.g. functional gauging, overlays)
- Review and improve the inspection plans containing the acceptance criteria, sampling methods, and measurement methods for products. Help ensure that the tolerances on initial drawings and prints are reasonable for functionality and DFM efforts
X-spine offers a challenging and customer focused work environment with competitive compensation and excellent benefits. Qualified and interested applicants should forward a resume and salary expectations/history to Human Resources at: firstname.lastname@example.org