Senior Quality Engineer

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

Job summary

Apollo Medical Extrusion Technologies, Inc. is seeking a Sr. Quality Engineer to oversee quality aspects of the product development process and ensure regulatory compliance. The role includes developing validation protocols and leading quality initiatives.

You will manage risk, drive continuous improvement via Lean/Six Sigma, and support data analytics using PowerBI and advanced Excel tools. On-site in Sandy, UT with competitive salary and benefits.

Qualifications

• Bachelor’s degree in Mechanical or Industrial Engineering (or foreign equivalent) with 5 years of relevant experience.
• Master’s degree with 3 years of related experience accepted as alternative
• Must have 1 year experience with SPC and automated measurement systems (vision systems, CMMs)

Responsibilities

• Work on quality aspects of product/process development ensuring regulatory compliance (ISO 13485, FDA QSR).
• Develop and execute validation protocols (TMV, IQ, OQ, PQ).
• Maintain Risk Management Files, dFMEAs, pFMEAs, and Control Plans.
• Lead automation initiatives including electronic QMS, Quality 4.0, and electronic SPC.
• Support Lean and Six Sigma improvements; drive CAPA and data-driven decisions.

Skills

Lean Six Sigma

Data analytics

SPC

Education

Bachelor’s degree in Mechanical or Industrial Engineering

Tools

CMMs

Vision systems

PowerBI

Excel VBA

Pivot Tables

Job description

Job Details

Job Location: Apollo Sandy - Sandy, UT 84070

Position Type: Full Time

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.

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.

Salary

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