Senior Quality Engineer: Lead QMS & Quality Excellence

Mativ Holdings, Inc.; Dallas, Northern (TX, KY); Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

PPO plan

EPO plan

Company-paid life insurance

Paid vacation and personal time off

401(k) with company match

Employee assistance programs

Wellness and work-life support

Job summary

Mativ Holdings, Inc. is seeking a Senior Quality Systems Engineer to drive quality improvements across manufacturing processes, develop CAPAs, and ensure compliance with FDA/ISO standards. The role collaborates with production and development teams to reduce defects and enhance product quality.

Responsibilities include leading QMS initiatives, performing RCA analyses, and mentoring junior engineers while staying current with industry best practices.

Qualifications

• Bachelor's degree in Engineering or related field with 8 years in senior quality roles.
• Experience applying CAPA and RCA methods (5-whys, Ishikawa, FMEA, DOE).
• Knowledge of regulatory standards (FDA/ISO) for medical devices, OTC drugs, cosmetics.

Responsibilities

• Lead quality improvement efforts by identifying bottlenecks and corrective measures.
• Write CAPAs and methods to capture quality metric data and monitor QMS.
• Ensure processes/documents conform to quality standards and regulatory requirements.
• Collaborate with Production Management to reduce defects and implement CAPA.
• Develop quality plans, risk analyses, and FMEAs with the team.
• Develop Process Monitoring Systems to reduce variation and defects.
• Evaluate product performance and identify improvements.
• Analyze quality data and report trends for corrective actions.
• Coordinate with internal departments to resolve quality issues.
• Interface with Regulatory, Notified Body or Client Audits and respond promptly.
• Stay updated with best practices and industry developments.
• Train and mentor junior quality assurance engineers.

Skills

CAPA & RCA

FMEA

SPC & CP/Cpk

IQ/OQ/PQ validations

QMS frameworks

Lean Six Sigma

FDA/ISO knowledge

cGMP & regulatory

Data analysis (Minitab/Excel)

Education

Bachelor's degree in Engineering

Tools

Minitab

Excel

Job description

Mativ Holdings, Inc. is seeking a Senior Quality Systems Engineer to drive quality improvements across manufacturing processes, develop CAPAs, and ensure compliance with FDA/ISO standards. The role collaborates with production and development teams to reduce defects and enhance product quality.

Responsibilities include leading QMS initiatives, performing RCA analyses, and mentoring junior engineers while staying current with industry best practices.