Sr. Quality Engineer

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world.

About the role

This is a full-time position located at 8181 Eastpoint Dr., Suite 300, Dallas, TX 75227, with a schedule of 40 hours per week, Monday through Friday.

Responsibilities

• Lead Quality improvement efforts by identifying quality bottlenecks and corrective measures to eliminate them.
• Write CAPAs, develop methods to capture quality metric data, and perform appropriate analysis to effectively monitor and enhance the Quality Management System (QMS).
• Assure new or modified processes or documents conform to quality standards and establish compliance with the quality system.
• Work with Production Management to reduce and control manufacturing process defects (scrap, nonconforming material, and customer complaints) by leading efforts/teams focused on identifying primary root causes and implementing corrective and preventative actions.
• Develop and implement product quality plans, documents, and systems by creating product specifications, quality specifications, quality plans, risk analyses, and FMEAs in conjunction with other product development team members.
• Work with Process Engineers to develop and implement Process Monitoring Systems by identifying critical processes and devising methods to reduce process variation to eliminate the cause of defects.
• Evaluate product performance, identify areas of improvement, and recommend solutions to ensure product quality.
• Analyze quality control data and develop reports to identify trends and recommend corrective actions.
• Coordinate and collaborate with internal departments to resolve quality issues.
• Interface with Regulatory, Notified Body, or Client Audits, assess possible findings, and respond to these in a timely manner.
• Ensure compliance with applicable industry standards and regulations.
• Stay up to date with best practices and industry developments related to quality assurance.
• Train and mentor junior quality assurance engineers.

Requirements

• Bachelor's degree (or foreign equivalent) in Computer Engineering, Systems and Industrial Engineering, or a related field of study.
• Eight (8) years of experience as a Sr. Quality Systems Engineer, Sr. Quality Assurance Engineer - Design Transfer, Quality Assurance Engineer, Quality Systems Manager, Quality Systems Coordinator, Site CAPA Coordinator, or related role.
• Eight (8) years of experience in the following areas:
  • Quality Assurance, auditing, and demonstrated knowledge using quality tools/methodologies such as process and equipment validations (IQ/OQ/PQ).
  • Applying CAPA and root-cause analysis tools (RCA) such as 5-whys, Fishbone/Ishikawa, FMEA, DOE, fault-tree analysis, and other structured problem-solving methods.
  • Applying statistical process control (SPC) methodologies including control charts, process capability analysis (Cp, Cpk, Pp, Ppk), capability studies for special-cause versus common-cause variation, Pareto analysis, trend analysis, and gauge R&R (MSA), as well as developing and applying sampling plans (ANSI/ASQ Z1.4, ISO 2859) using data analysis software tools such as Minitab and Excel.
  • FMEA development and maintenance.
  • FDA, ISO, and global regulatory standards applicable to medical devices, OTC drugs, and cosmetics to ensure compliance across product development and QMS activities.
  • Implementing, maintaining, and continuously improving QMS frameworks to drive consistent product quality and operational excellence.
  • Lean and Six Sigma methodologies, with practical experience applying process improvement tools to enhance product quality and operational performance.
  • Applying regulatory and industry standards including 21 CFR Part 820, ISO13485, 21 CFR Part 210/211, and 21 CFR Part 11.
  • Supporting manufacturing and quality activities for medical devices, OTC drugs, or cosmetics, including understanding specific cGMP (and other regulatory) requirements and standards.
  • Implementing and maintaining Quality Management System (QMS) elements such as Design Controls, Non-Conformances, CAPA, Complaint Handling, and Document Control.

Pay

$130,728 per year

Benefits

• Medical, dental, and vision insurance
• Consumer-Driven Health Plan (CDHP)
• Preferred Provider Organization (PPO)
• Exclusive Provider Organization (EPO)
• Company-paid basic life insurance and additional voluntary life coverage
• Paid vacation and competitive personal time off
• 401(k) savings plan with company match
• Employee assistance programs – available 24/7 to you and your family
• Wellness and Work Life Support, including career development and educational assistance