Senior Quality Engineer | Medical Devices & Validation Expert

Katalyst-Healthcares-; 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

Job Description:

Quality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives.
Roles & Responsibilities:

• Experience in a GMP and/or ISO regulated medical industry is required.
• Ability to analyze and present data that facilitates & drives decision making is required.
• The ability to perform "hands on " troubleshooting and problem solving is required Experience working in an FDA regulated environment is preferred.
• Experience working in operations supporting a production environment is preferred Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred
• Technical understanding of manufacturing equipment and processes is preferred Process Validation expertise is preferred.
• Ability to read and interpret CMM and dimensional inspection reports.
• Experience with dimensional data analysis utilizing software (Excel or Minitab)
• Experience in Medical Standards and Quality process preferred.
• New product launch experience from through full validation and commercial launch
• Experience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control Plan
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Performance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.
• Strong communication skills and ability to work well within a multidisciplinary team.
• Proficient with GD&T and interpreting technical drawings.
• Green or Black Belt Six Sigma certification preferred.

Requirements:

• Process Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R)
• Statistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab)
• Medical Device Quality Systems (GMP, ISO 13485, FDA Compliance)
• Bachelor in Mechanical Engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required.
• Required medical domain experience. Surgical Product and Implants experience preferred.