Senior Quality Engineer

Spectrum Plastics Group•Sandy, UT

2d•Onsite

About The Position

Apollo Medical Extrusion Technologies, Inc. is seeking a Senior Quality Engineer to work on the quality aspects of the Product/Process Development Process, ensuring compliance with regulatory requirements (ISO 13485, FDA QSR). This role involves developing and executing validation protocols, understanding customer requirements, maintaining risk management files, and serving as a quality representative in customer interactions. The position also includes training activities, acting as a subject matter expert for automated measurement systems, and driving automation initiatives. Additionally, the role focuses on quality systems and continuous improvement, including investigating customer complaints, conducting root cause analysis, and supporting process improvements through Lean and Six Sigma methodologies. The Senior Quality Engineer will make data-driven decisions, coordinate reporting, and ensure compliance with all quality requirements.

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.
OR 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.
Three (3) years demonstrated experience in completing lean-six sigma projects resulting in overall improvement of product quality, cost reduction and customer satisfaction.
One (1) year demonstrated experience working with Automated Measurement Systems like vision systems, CMMs etc.
One (1) year demonstrated experience working with Statistical Process Control (SPC).
One (1) year demonstrated experience in making quality scrap reduction and continuous improvement.
One (1) year demonstrated experience working with Data Analytics tools including PowerBI, Excel VBA, and Pivot Tables.
One (1) year demonstrated experience implementing and working with an Electronic Quality Management (eQMS) System.
Six (6) months demonstrated experience implementing and tracking Cost of Poor Quality (COPQ) Metrics and successfully reducing such costs.

Responsibilities

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.
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.