Senior Quality Engineer – Medical Devices & Compliance

HIGHRIDGE Inc.; Westminster (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

Highridge Medical is seeking a Quality Engineer to gather data, solve quality problems, and lead improvement projects. You will ensure products meet established requirements through audits, inspections, and testing, while collaborating with suppliers and internal teams to implement quality goals.

The role requires a BS in engineering, 5+ years in quality engineering (medical device preferred), and ASQ CQE/CRE certification is a plus.

Qualifications

• At least 5 years in a Quality Engineering role; medical device experience preferred.
• Understanding of ISO/QSR regulations and design assurance practices.
• Experience with FMEA, statistics, process control, and metrology.

Responsibilities

• Evaluate processes and equipment to meet performance and quality requirements.
• Establish quality plans for equipment and processes; monitor performance.
• Apply ISO/QSR requirements to processes; collaborate with suppliers on new product introductions.
• Assist Manufacturing, Sourcing and Development with regulatory interpretations.
• Develop and maintain department and project budgets.

Skills

Team collaboration

Quality engineering

Project planning

Communication

Statistics

GD&T knowledge

QSR/ISO regulations

FMEA

Metrology

Education

B.S. in engineering or related field

ASQ CQE or CRE preferred

5+ years in Quality Engineering

Tools

Optical comparators

CMMs

Job description

Highridge Medical is seeking a Quality Engineer to gather data, solve quality problems, and lead improvement projects. You will ensure products meet established requirements through audits, inspections, and testing, while collaborating with suppliers and internal teams to implement quality goals.

The role requires a BS in engineering, 5+ years in quality engineering (medical device preferred), and ASQ CQE/CRE certification is a plus.