Quality Engineer I: Medical Devices & Process Quality

Regulatory Jobs; Versailles (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Regulatory Jobs is seeking a quality engineer to identify, investigate, plan, and conduct activities to improve quality in the design and manufacturing of medical devices and components.

You will collaborate cross-functionally with R+D engineering, manufacturing, technical service, and supply chain to manage quality, regulatory compliance, and cost. Bachelor's degree in engineering and 2+ years of related experience are required; Six Sigma Green Belt is preferred.

Qualifications

• Bachelor's degree in engineering or related field and 2+ years relevant experience.
• Six Sigma Green Belt certification preferred.

Responsibilities

• Ensures products and changes comply with FDA, ISO, UL, CSA, etc.
• Develops, maintains, and improves the QMS for regulatory compliance.
• Drives product quality improvements with design, manufacturing, and supply chain.
• Identifies testing and validation opportunities and contributes to improvements.
• Works on moderately complex projects, generates alternatives, and conducts testing.
• Applies Six Sigma methods to identify opportunities for improvements.
• Conducts the design and process FMEA process.
• Participates in Design Control Process (design input/output, reviews, validations).
• Identifies risks, communicates them, and mentors junior engineers.
• Applies advanced engineering methods and tools to solve problems.

Skills

Engineering problem solving

Communication

Process improvement

Education

Bachelor's degree in engineering or related field

Six Sigma Green Belt certification

Tools

Microsoft Word

PowerPoint

Excel

MS Project

Minitab

Job description

Regulatory Jobs is seeking a quality engineer to identify, investigate, plan, and conduct activities to improve quality in the design and manufacturing of medical devices and components.

You will collaborate cross-functionally with R+D engineering, manufacturing, technical service, and supply chain to manage quality, regulatory compliance, and cost. Bachelor's degree in engineering and 2+ years of related experience are required; Six Sigma Green Belt is preferred.