Quality Engineer

Quality Engineer

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.
• 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/DFMEAs, Gage R&Rs, TMVs, Risk Assessments, and Control Plans.
• 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.

• Process Validation & Quality Engineering
• IQ/OQ/PQ
• Test Method Validation (TMV)
• PFMEA / DFMEA
• Gage R&R
• Statistical Analysis
• Six Sigma
• SPC
• DOE
• MSA
• Minitab
• Medical Device Quality Systems
• GMP
• ISO 13485
• FDA Compliance
• Risk Assessments
• Control Plans
• Process Characterization
• Process Capability Analysis
• First Article Inspection (FAI)
• Supplier Qualification
• GD&T
• Dimensional Data Analysis
• CMM Reports
• Root Cause Analysis
• Lean Manufacturing
• Manufacturing Processes
• Medical Devices
• Surgical Products
• Implants

• 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.
• Surgical Product and Implants experience preferred.
• Experience working in GMP and/or ISO regulated medical environments.
• Experience working in FDA-regulated environments preferred.
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.
• Green or Black Belt Six Sigma certification preferred.