Senior Quality Engineer

DuPont™ Spectrum™; Sandy (UT); On-site; USD 118,000 - 128,000; Full time

Job summary

Apollo Medical Extrusion Technologies, Inc. seeks a Sr. Quality Engineer to ensure regulatory compliance (ISO 13485, FDA QSR) and drive robust quality programs in product and process development at our Sandy, Utah site.

You'll develop validation protocols (TMV, IQ/OQ/PQ), maintain risk management files, lead CAPA investigations, and support supplier quality and internal audits while advancing Quality 4.0, eQMS, and data analytics with PowerBI and Minitab.

Qualifications

• Bachelor’s degree in Mechanical or Industrial Engineering required.
• Master’s degree in the same field accepted with 3 years experience.
• Five years of Quality Engineer or related experience; Lean Six Sigma projects preferred.

Responsibilities

• Ensure regulatory compliance (ISO 13485, FDA QSR) for product/process development.
• Develop/execute validation protocols (TMV, IQ/OQ/PQ) and risk management files.
• Lead CAPA investigations, root cause analysis, and corrective actions.
• Support customer interactions, supplier quality, and internal audits.
• Drive automation initiatives, eQMS, and Quality 4.0; analyze data with PowerBI/Minitab.

Skills

Quality engineering

Root cause analysis

CAPA

Lean Six Sigma

Data analytics

Education

Bachelor’s degree in Mechanical or Industrial Engineering

Master’s degree in Mechanical or Industrial Engineering

Tools

Automated measurement systems

Vision systems

CMMs

PowerBI

Excel VBA

Pivot Tables

eQMS

Minitab

DOE

Gage R&R

Job description

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.

Qualifications

REQUIREMENTS: Bachelor’s degree, or foreign equivalent, in Mechanical or Industrial Engineering, or a related field and Five (5) years of experience as a Quality Engineer, Continuous Improvement Engineer, Manufacturing Engineer, Industrial Engineer, or related occupation. Employer will accept a Master’s degree, or foreign equivalent, in Mechanical or Industrial Engineering, or a related field plus three (3) years of experience as a Quality Engineer, Continuous Improvement Engineer, Manufacturing Engineer, Industrial Engineer, or related occupation.

• Completing lean-six sigma projects resulting in overall improvement of product quality, cost reduction and customer satisfaction.

Must have one (1) year demonstrated experience in each of the following:

• Working with Automated Measurement Systems like vision systems, CMMs etc.
• Working with Statistical Process Control (SPC).
• Making quality scrap reduction and continuous improvement.
• Working with Data Analytics tools including PowerBI, Excel VBA, and Pivot Tables.
• Implementing and working with an Electronic Quality Management (eQMS) System.

Must have six (6) months demonstrated experience in each of the following:

• Implementing and tracking Cost of Poor Quality (COPQ) Metrics and successfully reducing such costs.

OFFERED WAGE: $118,186 – $128,186/year