RESPONSIBILITIES:Kforce has a client that is seeking a Medical Device Quality Inspector in Tempe, Arizona (AZ).
This position is responsible for providing quality technical support within manufacturing and system/services support and for assisting quality engineers in developing and maintaining quality engineering methodologies.
- Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results
- Responsible for conducting measurements of silicone, rubber, and plastic pieces and assemblies per drawings and specifications
- Perform final product inspections against drawings, specifications, and procedural requirements
- Document non-conformance's as appropriate
- Monitor status of calibration and maintenance of all test equipment and fixtures
- Perform Process Control & Monitoring of critical-to-quality parameters and specifications
- Collect data, summarize, and document test results
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Responsible for maintaining document traceability analysis of engineering requirements, ISO documents related to part measurement, and training others within department as needed
- High School diploma or GED/equivalent required
- ASQ CQT certification or equivalent preferred
- 2-year technical degree preferred
- 2-4 years of experience working as a Quality Technician and/or Quality Inspector in medical device companies
- Training in blueprint and drawing reading and experience with sampling techniques
- Experience with optical measurement equipment, hand tools, gages, pressure and force gages, CMMs, and test fixtures
- Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements
- Good communication and computer skills, including data analysis and report writing skills
- Strong visual inspection experience is desired
- Prior medical device experience is a must
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.