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.
