Sr. Quality Engineer

Mativ•Dallas, TX

14h•Onsite

About The Position

This role involves leading quality improvement efforts, identifying bottlenecks, and implementing corrective measures. The Sr. Quality Engineer will be responsible for writing CAPAs, capturing and analyzing quality metric data to enhance the Quality Management System (QMS), and ensuring new or modified processes and documents comply with quality standards and the quality system. The position also involves working with Production Management to reduce manufacturing defects by identifying root causes and implementing corrective and preventative actions, developing product quality plans, specifications, risk analyses, and FMEAs. Collaboration with Process Engineers to develop Process Monitoring Systems, evaluating product performance, analyzing quality control data, and coordinating with internal departments to resolve quality issues are key aspects of this role. Additionally, the engineer will interface with regulatory bodies and clients during audits, ensure compliance with industry standards and regulations, stay updated on best practices, and train junior quality assurance engineers.

Requirements

Bachelor's degree (or foreign equivalent) in Computer Engineering, Systems and Industrial Engineering, or 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.
8 years of experience in Quality Assurance.
8 years of experience in auditing.
Demonstrated knowledge using quality tools/methodologies such as process and equipment validations (IQ/OQ/PQ).
Experience applying CAPA and root-cause analysis tools (RCA) tools such as 5-whys, Fishbone/Ishikawa, FMEA, DOE and fault-tree analysis, and other structured problem-solving methods.
Experience 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).
Experience applying the development and application of sampling plans (ANSI/ASQ Z1.4, ISO 2859).
Experience using data analysis software tools such as Minitab and Excel.
Experience with FMEA development and maintenance.
Experience with FDA, ISO and global regulatory standards applicable to medical devices, OTC drugs and cosmetics to ensure compliance across product development and QMS activities.
Experience implementing, maintaining, and continuously improving QMS frameworks to drive consistent product quality and operational excellence.
Experience with Lean and Six Sigma methodologies, with practical experience applying process improvement tools to improve product quality and operational performance.
Experience applying regulatory and industry standards including 21 CFR Part 820, ISO13485, 21 CFR Part 210/211 and 21 CFR Part 11.
Experience supporting manufacturing and quality activities for medical devices, OTC drugs or cosmetics, including understanding of specific cGMP (and other regulatory) requirements and standards.
Experience implementing and maintaining Quality Management System (QMS) elements such as Design Controls or Non-Conformances, CAPA, Complaint Handling and Document Control.

Responsibilities

Lead Quality improvement efforts by identifying quality bottlenecks and corrective measures.
Write CAPAs, methods to capture quality metric data and performs appropriate analysis to effectively monitor and enhance the Quality Management System (QMS).
Assure new or modified processes or documents conform to quality standards and establishes 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 the 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, FMEAs in conjunction with other product development team members.
Work with Process Engineer to develop and implement Process Monitoring Systems by identifying critical process and devising methods to reduce process variation in order to reduce/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 and assessing possible findings and responding 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.