Summary:
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's 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.
