Senior Quality Engineer | Medical Devices & Validation Expert

Creative Solutions Services, LLC; San Antonio (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Engineer with 5+ years in the medical device industry. The role focuses on quality, validation, and manufacturing engineering for surgical products and implants in GMP/ISO environments.

The candidate will perform process validation, PFMEA/DFMEA, Gage R&R, SPC, DOE, and risk assessments, with strong GD&T and data analysis skills. Hands-on troubleshooting in production is required.

Qualifications

• Experience in GMP/ISO regulated medical industry.
• Ability to analyze and present data that facilitates decision making.
• Hands-on troubleshooting in FDA-regulated environments.
• Lean and Six Sigma methodologies (SPC, DOE, MSA, etc.).
• Technical understanding of manufacturing equipment and processes.
• Ability to read CMM and dimensional inspection reports.
• Proficient in GD&T interpretation.

Responsibilities

• Perform data analysis to drive decision making in GMP/ISO medical environments.
• Support quality, validation, and manufacturing engineering in production operations.
• Engage in troubleshooting and problem solving in a hands-on capacity.
• Contribute to PFMEA/DFMEA, control plans, and process validations.
• Analyze dimensional data and supplier qualifications as part of quality improvements.

Skills

Data analysis

Root cause analysis

Cross-functional collaboration

Problem solving

Gage R&R

SPC

DOE

MSA

GD&T interpretation

New product validation

Education

Bachelor's in Mechanical Engineering or equivalent

Tools

Minitab

Excel

Job description

Creative Solutions Services, LLC is seeking a Quality Engineer with 5+ years in the medical device industry. The role focuses on quality, validation, and manufacturing engineering for surgical products and implants in GMP/ISO environments.

The candidate will perform process validation, PFMEA/DFMEA, Gage R&R, SPC, DOE, and risk assessments, with strong GD&T and data analysis skills. Hands-on troubleshooting in production is required.