Quality Engineering Tech

Intuitive•Durham, NC

About The Position

The Quality Engineering Tech drives quality assurance and quality control methodologies within sustaining manufacturing teams and environments at the ATM site. This role supports monitoring quality metrics, identifying underlying causes of quality defects, and performing quality screening for advanced tissue models and associated equipment. The position supports sustaining quality operations by reporting on quality metrics, leading quality initiatives, supporting manufacturing processes through failure analysis and defect containment, reviewing shipping and export documents for regulatory compliance, and conducting root cause analysis. It also identifies opportunities to improve processes and procedures, efficiency, effectiveness, yields, and waste reduction. The role evaluates product quality through material inspections, including FQI and IQC, for 4 to 8 hours per week as needed. It may involve travel to local tissue harvest sites for up to 8 hours per week as needed to address quality events and advise on material requirements. The technician also troubleshoots quality issues, recommends process improvements, and redlines MPIs and QC inspection criteria to improve clarity and process flow.

Requirements

High school diploma or equivalent.
Minimum two years of relevant experience.
Basic understanding of Quality Systems and regulatory compliance processes, including requirements for making process changes.
Technical writing skills, including the ability to create and review procedures.
Risk management mindset and ability to make decisions using a risk-based approach.
Good grasp of basic quality assurance and quality control processes and tools.
Ability to interact positively with employees, vendors, and suppliers from varied backgrounds.
Understanding of data analysis tools and operations, such as Pareto analysis, charts, and trends.

Nice To Haves

Bachelor’s degree in engineering, preferably biomedical, mechanical, or systems engineering, or in math, physics, or another science.
ASQ Certification as a Quality Improvement Associate and/or Quality Process Analyst.
Exposure to Lean Manufacturing or Six Sigma methodologies.
Basic understanding of root cause investigation processes.
Understanding of risk management techniques.
Basic understanding of project management principles.
Bilingual in English and Spanish.

Responsibilities

Monitor and compile reports on quality metrics.
Lead and project-manage quality initiatives and processes.
Support product manufacturing processes, including failure analysis and defect containment.
Review shipping and export documents for regulatory compliance.
Perform root cause analysis and propose solutions to challenges.
Identify opportunities to improve processes and procedures, efficiency, effectiveness, yields, and waste reduction.
Evaluate product quality by performing material inspections, including FQI and IQC, for 4 to 8 hours per week as needed.
Travel to local tissue harvest sites, up to 8 hours per week as needed, to address quality events and advise on material requirements.
Detect, report, and troubleshoot quality issues and suggest robust process improvements.
Redline MPIs and QC inspection criteria to clarify requirements and improve process flow.