Quality Engineer
Apolis
Job Title: Quality Engineer Location: Cincinnati, OH (Onsite) Tax Term: W2 Job Type:Contract Duration: Long-Term Contract 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 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.
Vacancy posted 2 days ago
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