The Senior QA Technician will be responsible for gauging, calibration, CMM programing, OGP/Smartscope/Vision system programming, inspection sheets & validation (PPAP) report writing, and other duties in support of the Quality Engineering functions. This position is necessary to provide accurate and timely development of inspection systems and product onboarding. The ability to apply metrology, GD&T and experience in programing CMMs, vision systems is required.
Key Result Accountabilities:
- Lead or oversee the maintenance of systems that monitor the accuracy of all measurement and test equipment.
- Lead or oversee calibration as required for all company owned equipment as well as personal tools.
- Lead or oversee the repair of gauges as needed; if unable to do internally, send to an outside repair service and /or request a replacement.
- Create inspection sheets and measurement methods as required.
- Assist customers and suppliers in duplicating our inspection techniques and meeting product specifications.
- SME for CMM (PCDIMIS, Brown and Sharp), vision system (OGP/Smartscope), Laser mike and various hand tools.
- Develop gauging methods in the facility, including roundness checker, profilometer, and height stands.
- Train and mentor operators and QC staff in the developing their expertise in GD&T and other blueprint and dimensioning methods.
- Support Quality Engineering staff in the creation of PPAP documentation
- Assist in the development of validation reports
- Assist in the development of control plans
- Assist in the development of Infinity QS programs
- Technical degree or certification and 3 years equivalent experience in similar regulated field; Medical Device experience strongly preferred
- CMM and vision system programing experience strongly preferred.
- GD&T, blueprint reading, inspection sheet creation required.
- Experience with Infinity QS or similar software for real time SPC (statistical process controls) a plus.
- Experience with MS-Word, Excel, Access, and Power Point for word processing and documentation support
- Good teamwork and communication skills to facilitate training and group problem solving
- Must be able to complete multiple prioritized tasks with minimal direct supervision, while maintaining focus on preventative activities
- Complete all job-specific required training
- Ability to understand and comply with the FDA’s Quality Systems Regulations (QSR) and ISO 13485:2003 standards a plus
- ASQ certification as a CMI, CCT, or CQT is strongly preferred or required within one year of being in the position
Environmental Working Conditions
Job tasks may also involve:
- Using personal protective equipment such as safety glasses, goggles, gloves, and other equipment as established in company policies and safe work procedures
- Working near cutting & machining fluids, solvents, lubricants and other hazardous chemicals using appropriate safety controls
- Lifting up to 50 pounds
- Frequent carrying, bending, standing, sitting, and repetitive motion