Senior Quality Engineer - Medical Devices & QMS Leader

BioMed Laboratories LLC; Mesquite (TX); On-site; USD 111,000 - 150,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) retirement plan with company匹配

Job summary

BioMed Laboratories, LLC seeks a Sr. Quality Engineer to lead quality improvements and ensure QMS compliance in a medical device environment. You will drive CAPA programs, write validation plans, and collaborate with production to reduce defects.

The role requires a bachelor’s in engineering and 8+ years in quality systems, with experience in FDA/ISO standards, FMEA, SPC, and lean six sigma. Location: Dallas, TX, full-time.

Qualifications

• Bachelor's degree in Computer Engineering, Systems and Industrial Engineering, or related field.
• Eight years of senior quality systems/QA experience in medical devices or related industries.
• Experience with CAPA, RCA, SPC and regulatory standards (FDA/ISO).

Responsibilities

• Lead quality improvement efforts to remove bottlenecks and drive CAPA effectiveness.
• Develop and maintain QMS processes, documents, and quality plans.
• Collaborate with production to reduce defects and scrap via root-cause action.
• Create and analyze product and process metrics to support quality decisions.
• Coordinate audits with regulators, notified bodies, and clients as needed.
• Mentor junior quality engineers and ensure regulatory compliance.

Skills

CAPA & RCA tools

Statistics & SPC

FMEA

DOE

Measurement systems analysis (MSA)

QMS implementation

Regulatory knowledge (FDA/ISO)

Lean Six Sigma

Data analysis (Excel, Minitab)

Education

Bachelor's degree in Computer Engineering, Systems and Industrial Engineering

Tools

Minitab

Excel

Job description

BioMed Laboratories, LLC seeks a Sr. Quality Engineer to lead quality improvements and ensure QMS compliance in a medical device environment. You will drive CAPA programs, write validation plans, and collaborate with production to reduce defects.

The role requires a bachelor’s in engineering and 8+ years in quality systems, with experience in FDA/ISO standards, FMEA, SPC, and lean six sigma. Location: Dallas, TX, full-time.