Senior Quality Engineer

DuPont™ Spectrum™; Sandy (UT); On-site; USD 95,000 - 135,000; Full time

Job summary

Apollo Medical Extrusion Technologies, Inc. in Sandy, Utah seeks a Sr. Quality Engineer to drive quality initiatives across product and process development. You will validate processes, manage risk, and act as the quality liaison with customers.

The role emphasizes ISO 13485 and FDA QSR compliance, CAPAs, data analytics with PowerBI, and training across both salaried and hourly staff. A strong Six Sigma background is preferred.

Qualifications

• Bachelor’s degree in Mechanical or Industrial Engineering or related field.
• Master’s degree in Mechanical or Industrial Engineering is acceptable with 3 years of related experience.
• Five years of experience as a Quality Engineer or related role.
• Master’s plus three years of related experience accepted as alternative.

Responsibilities

• Develop and execute validation protocols (TMV, IQ, OQ, PQ) ensuring regulatory compliance.
• Maintain Risk Management Files, dFMEAs, pFMEAs, and Control Plans.
• Serve as quality representative in customer calls and interactions.
• Lead training for employees on quality systems and GD&T interpretation.
• Drive automation initiatives including electronic QMS and PowerBI-based KPIs.

Skills

Lean Six Sigma

Statistical Analysis

Quality Systems

CAPA

Education

Bachelor's degree in Mechanical or Industrial Engineering

Master’s degree in Mechanical or Industrial Engineering

Tools

Vision-based CMMs

PowerBI

Excel VBA

eQMS

Job description

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.

Must have (3) years demonstrated experience in each of the following:

• 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.