Senior Quality Engineer: CAPA, QMS & Process Improvement

Mativ; Dallas (TX); On-site; USD 120,000 - 141,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Paid vacation

Job summary

BioMed Laboratories, LLC is seeking a Sr. Quality Engineer to lead quality improvement, CAPA development, and QMS optimization on-site in Dallas, TX. The role requires extensive experience with CAPA, RCA, FMEA, SPC and regulatory compliance.

You will collaborate with manufacturing and process engineering to reduce defects, implement preventive actions, and maintain robust quality processes across the product lifecycle.

Qualifications

• Eight years of experience in senior quality roles with CAPA, RCA and QMS responsibilities.
• Experience applying statistical tools (SPC, Cp/Cpk) and quality methodologies (FMEA, DOE).
• Knowledge of FDA/ISO regulations for medical devices, OTC drugs or cosmetics.
• Demonstrated ability to lead cross-functional teams and manage CAPA programs.

Responsibilities

• Lead quality improvement efforts to identify bottlenecks and corrective actions.
• Write CAPAs, capture quality metrics data and monitor QMS effectiveness.
• Ensure processes/documents comply with quality standards and regulatory requirements.
• Collaborate with Production to reduce defects and implement corrective actions.

Skills

CAPA

Root-cause analysis

FMEA

SPC

DOE

Gage R&R

QMS

Minitab

FDA/ISO compliance

Excel

Education

Bachelor's degree in Computer Engineering, Systems and Industrial Engineering, or related field

Tools

Minitab

Excel

Job description

BioMed Laboratories, LLC is seeking a Sr. Quality Engineer to lead quality improvement, CAPA development, and QMS optimization on-site in Dallas, TX. The role requires extensive experience with CAPA, RCA, FMEA, SPC and regulatory compliance.

You will collaborate with manufacturing and process engineering to reduce defects, implement preventive actions, and maintain robust quality processes across the product lifecycle.