Quality Engineer — Medical Devices & Process Improvement

Highbrow Technology Inc; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Highbrow Technology Inc is seeking a Quality Engineer to develop and maintain quality engineering methodologies and provide quality engineering support across new product development, manufacturing, or system/services support.

You will lead process control, CAPA, risk analysis, and use Six Sigma and Lean tools to improve product and process quality in a highly regulated medical device context.

Qualifications

• Minimum 2 years engineering experience with quality tools and methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, ISO 14971.
• Strong communication and leadership across multi-department teams.

Responsibilities

• Lead process control and CAPA systems to meet requirements.
• Design and conduct experiments for process optimization.
• Document experiment plans, reports and verification activities.
• Lead investigations and prevention of non-conformances.

Skills

Quality tools

Six Sigma

Lean Manufacturing

Project management

Statistical analysis

Communication skills

Leadership

Education

Engineering or Technical Field

Equivalent experience

Tools

ASQ CQE

Job description

Highbrow Technology Inc is seeking a Quality Engineer to develop and maintain quality engineering methodologies and provide quality engineering support across new product development, manufacturing, or system/services support.

You will lead process control, CAPA, risk analysis, and use Six Sigma and Lean tools to improve product and process quality in a highly regulated medical device context.