Quality Engineer - Johnson & Johnson

Belcan Corporation; Cincinnati (OH); On-site; USD 69,000 - 83,000; Full time

Job summary

Belcan Corporation is seeking a Quality Engineer for a 24‑month contract in Cincinnati, OH. The role focuses on quality, validation, and manufacturing engineering for surgical products and implants, with strong emphasis on process validation, PFMEA/DFMEA, and GMP/ISO compliance.

Ideal candidates have 6–8 years in medical device quality and hands-on problem solving. Responsibilities include data-driven decision making, working in a cross-functional team, and ensuring documentation meets

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent; minimum 5 years in Quality/Validation/Manufacturing Engineering in medical devices.
• Experience in GMP/ISO regulated environments and surgical products/implants preferred.
• Hands-on problem solving and data-driven decision making are required.

Responsibilities

• Regulatory and quality documentation compliance across projects.
• Analyze data to drive informed decisions and support manufacturing operations.
• Hands-on troubleshooting in production and process validation efforts.
• Lead PFMEA/DFMEA, Gage R&R, and control plans for new components.
• Interpret GD&T and CMM reports; collaborate cross-functionally.

Skills

Quality engineering

Data analysis

Troubleshooting

GD&T

Six Sigma

CMM interpretation

Regulatory compliance

Manufacturing processes

Education

Bachelor's in Mechanical Engineering

5+ years medical device quality experience

Tools

Minitab

Excel

Job description

Description: Job Title: Quality Engineer
Pay Rate: $50-60/hr
Duration: 24-month contract
Location: Cincinnati, OH
Zip Code: 45242
Start Date: Right Away
Keywords: #QualityEngineerJobs

Summary:

Quality Engineer with 6 to 8 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.

Required Qualifications:

• The Candidates should be Bachelor 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.

Equal Opportunity Statement:

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.