Maintain systems that monitor the accuracy of all measurement and test equipment.
Calibrate as required all company owned equipment as well as personal tools.
Repair gages as needed; if unable to do internally, send to an outside repair service and /or request a replacement.
In process inspection as required.
Inspect vendor supplied components / assemblies.
Assist suppliers in duplicating our inspection techniques and meeting our product specifications.
Laser inspection (First piece Laser certification).
Inspect vendor work with the Smartscope V.M.M.
Use all gaging methods in the facility, including roundness checker, profilometer, and height stands.
Develop expertise in GD&T and other blueprint and dimensioning methods.
Train associates on laser inspection and assist in obtaining certification.
Document any discrepancies
Control of Non-Conforming material/ parts are Quarantined to prevent shipment
Certify documentation (i.e.: Certification, first article data, process capability study, etc.) prior to shipment against C of C (provided in traveler packet)
Verify packaging matches specified requirements (where indicated) or is adequate if no specific requirements exist.
Verify customer purchase order requirements (provided in traveler packet)
Verify / sign completed MSC-10.01 shipment verification review form.
Comply with work rules including safety, health, quality system, and Company Quality Management Systems
Assist in investigating and preventing customer complaints
Work with customers and suppliers to implement corrective and preventive actions
Participate in Internal Quality Audits, following Internal Audit training
When asked, serve as a member of Continuous Improvement teams
High School diploma or GED, plus 4 years experience in Quality and/or Operations
Technical degree and 2 years equivalent experience in similar regulated field; Medical Device experience strongly preferred
Laser inspection experience
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
CMM Certified Operator
WOTC, tax credits, background checks, human resources