Senior Quality Engineer
THIS NOTICE IS BEING PROVIDED AS A RESULT OF THE FILING OF AN APPLICATION FOR PERMANENT ALIEN LABOR CERTIFICATION FOR THIS JOB OPPORTUNITY. ANY PERSON MAY PROVIDE DOCUMENTARY EVIDENCE BEARING ON THIS APPLICATION TO CERTIFYING OFFICER OF THE U.S. DEPARTMENT OF LABOR (Certifying Officer, U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210)
COMPANY: Apollo Medical Extrusion Technologies, Inc.
POSITION: Sr. Quality Engineer
LOCATION: 8760 South Sandy Parkway, Suite 200, Sandy, UT 84070
JOB DUTIES: Work on quality aspects of the Product/Process Development Process, ensuring compliance with regulatory requirements (ISO 13485, FDA QSR). Develop and execute validation protocols, including Test Method Validation (TMV), Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ). Understand customer requirements and transfer the knowledge to the process development for higher FPY and success of existing and new projects. Maintain Risk Management Files, dFMEAs, pFMEAs, and Control Plans. Support customer calls and be the quality representative in such interactions. Participate in training activities including salaried and hourly employees. Serve as the subject matter expert for programming and validating vision-based and touch-probe CMMs (MicroVu, Keyence, Laserlinc, Zumbach). Work on inspection method development, qualification (TMV, Gage R&R), and statistical analysis (SPC, DOE). Drive automation initiatives, including electronic QMS, Quality 4.0, and electronic SPC implementation. Assist in fixture design and work-holding solutions to optimize measurement processes. Provide training on automated measurement systems and GD&T interpretation. Quality Systems & Continuous Improvement. Investigate customer complaints and NCRs, conduct root cause analysis, and implement corrective/preventive actions (CAPA). Act as a consultant for quality system processes, including supplier quality, internal audits, environmental monitoring, and training. Support process improvements through Lean and Six Sigma methodologies. Make data-driven decisions and coordinate reporting using statistical tools (Minitab, Excel). Ensure compliance with regulatory, customer, and internal quality requirements. Develop site wide KPIs with modern data analytics tools like PowerBI.