Quality Engineering Tech

Job description

Primary Function of Position The Quality Engineering Tech will drive quality assurance and quality control methodologies within sustaining manufacturing teams and environments at the ATM site. This position requires a highly motivated team player to support monitoring of quality metrics, identify underlying causes of quality defects, and perform quality screening for advanced tissue models and associated equipment.

Essential Job Duties

Sustaining Quality Operations

• Monitor and compile reports on quality metrics
• Lead and project manage various quality initiatives and processes
• Provide support to product manufacturing processes, including failure analysis and defect containments
• Review shipping and export documents for compliance to regulations
• Perform root cause analysis and propose solutions to challenges encountered Continuously implementing items found while interacting with manufacturing and quality processes by identifying areas of opportunity within processes and procedures to improve efficiency, effectiveness, yields, eliminate waste and overall to improve the business

Product Quality Support

• Evaluate product quality by performing material (FQI, IQC, etc.) inspections 4 to 8 hours per week, as needed Travel to local tissue harvest sites to address quality events and advise on material requirements up to 8 hours per week, as needed Detect, report, and troubleshoot quality issues and suggest robust process improvements to drive a culture of quality Redline MPIs and QC inspection criteria for clarification and process flow improvements.

Qualifications

Required Skills and Experience

Basic understanding of Quality Systems and Regulatory Compliance process including requirements for making process changes Technical writing skills including ability to both create and review procedures Risk management mindset to drive decisions with a risk-based approach Good grasp of basic quality assurance/control processes and tools

• Ability to have positive interactions with employees, vendors, suppliers with varied backgrounds
• Understands data analysis tools and operations (e.g,.

Pareto, charts, and trends)

Required Education and Training Education

High school diploma or equivalent; minimum two years of relevant experience.

Working Conditions

• Must be able to sit for extended periods of time (up to 8 hours)
• Must be able to lift a minimum of 25 lbs
• Must be able to traverse manufacturing and design spaces

Preferred Skills and Experience

Bachelor’s degree in engineering (prefer biomedical, mechanical or system), math, physics or other sciences. ASQ Certification as Quality Improvement Associate and/or Quality Process Analyst Exposure to Lean Manufacturing / Six Sigma methodologies Basic understanding of root cause investigation process Understanding of Risk Management techniques Basic understanding of project management principles Bi-lingual in English and Spanish