Senior Quality Engineer

Apollo Medical Extrusion; Sandy (UT); On-site; USD 90,000 - 120,000; Full time

Job summary

Apollo Medical Extrusion Technologies, Inc. is seeking a Senior Quality Engineer to own quality across product and process development.

The role requires ensuring compliance with ISO 13485 and FDA QSR, developing validation protocols (TMV/IQ/OQ/PQ), and maintaining risk management files. The successful candidate will lead data-driven quality improvements using SPC, COPQ tracking, and advanced analytics (PowerBI, Excel VBA).

Qualifications

• Bachelor’s degree in Mechanical or Industrial Engineering or related field is required.
• Five years of experience as a Quality Engineer or related role is required.
• Experience with Lean-Six Sigma projects and COSQ metrics is required.

Responsibilities

• Oversee quality aspects of product and process development per ISO 13485 and FDA QSR.
• Develop and execute validation protocols (TMV, IQ, OQ, PQ).
• Maintain risk management files including dFMEAs and pFMEAs and control plans.

Skills

Lean Six Sigma

Data Analytics

SPC

PowerBI

Excel VBA

Gage R&R

CAPA

GD&T

Education

Bachelor’s degree in Mechanical or Industrial Engineering

Master’s degree in Mechanical or Industrial Engineering (optional)

Tools

CMMs (Vision systems)

Gage R&R tools

Job description

COMPANY: Apollo Medical Extrusion Technologies, Inc.POSITION: Sr. Quality EngineerLOCATION: 8760 South Sandy Parkway, Suite 200, Sandy, UT 84070JOB 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.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.CONTACT: Please apply via company intranet and keyword search job code # 000153 to apply