Manufacturing quality engineering

Job Title: Quality Engineer
Tax Term: W2
Job Type:Contract
Duration: Long-Term Contract
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.
Experience in a GMP and/or ISO regulated medical industry is required.
Ability to analyze and present data that facilitates and drives decision making is required.
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.) Technical understanding of manufacturing equipment and processes 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/DFMEAs, Gage R&Rs, TMVs, Risk Assessments, and Control Plans.
Performance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.
Process Validation & Quality Engineering
Statistical Analysis
Medical Device Quality Systems
Risk Assessments
Process Capability Analysis
First Article Inspection (FAI)
Dimensional Data Analysis
Root Cause Analysis
Lean Manufacturing
Manufacturing Processes
Medical Devices
Bachelor's degree in Mechanical Engineering or equivalent.
Minimum 5 years of experience working in a Quality, Validation, and/or Manufacturing Engineering role in the Medical Product industry.
Required medical domain experience.
Experience working in GMP and/or ISO regulated medical environments.