Quality Engineer

L&T Technology Services; Draper (UT); On-site; USD 90,000 - 120,000; Full time

Job summary

L&T Technology Services is seeking a Senior Engineer to drive manufacturing process improvement and quality engineering in a regulated medical device environment. The role focuses on developing, validating, and optimizing processes, while leading cross-functional teams and ensuring compliance with change controls and documentation standards.

The ideal candidate will apply Six Sigma, Lean, and risk-management practices to secure product quality and regulatory adherence across manufacturing

Qualifications

• Bachelor’s degree in Engineering or related field.
• 5–7 years of engineering experience.
• Experience in Manufacturing/Process/Quality Engineering.
• Strong knowledge of Six Sigma and Lean Manufacturing.
• Experience with statistical techniques and engineering problem-solving.
• Experience with process/equipment validation.
• Ability to read and interpret engineering drawings.
• Strong documentation, communication, and leadership skills.
• Experience working in a regulated manufacturing environment.

Responsibilities

• Lead manufacturing process identification, development, and optimization.
• Drive Lean / Six Sigma and continuous improvement initiatives.
• Develop and optimize equipment, tooling, fixtures, and manufacturing processes.
• Lead experiments, testing, and process improvement activities.
• Investigate complex quality issues including NCR, CAPA, SCAR, MRB, and non-conformances.
• Develop and maintain risk management documentation.
• Support equipment selection and validation.
• Create work instructions, training materials, and technical documentation.
• Lead and approve compliant change controls.
• Collaborate with Quality, Manufacturing, Engineering, suppliers, and cross-functional teams.

Skills

Lean Six Sigma

Leadership

Documentation

Problem solving

Communication

Quality Engineering

Education

Bachelor’s degree in Engineering or related field

Tools

Statistical methods

Process validation

GMP

Risk management

Job description

We are looking for a Senior Engineer with strong experience in manufacturing process improvement, quality engineering, process validation, and continuous improvement to support a regulated medical device manufacturing environment.

Key Responsibilities

• Lead manufacturing process identification, development, and optimization
• Drive Lean / Six Sigma and continuous improvement initiatives
• Develop and optimize equipment, tooling, fixtures, and manufacturing processes
• Lead experiments, testing, and process improvement activities
• Investigate complex quality issues including NCR, CAPA, SCAR, MRB, and non-conformances
• Develop and maintain risk management documentation
• Support equipment selection and validation
• Create work instructions, training materials, and technical documentation
• Lead and approve compliant change controls
• Collaborate with Quality, Manufacturing, Engineering, suppliers, and cross-functional teams

Required Qualifications

• Bachelor’s degree in Engineering or related field
• 5–7 years of engineering experience
• Manufacturing / Process / Quality Engineering experience
• Strong knowledge of Six Sigma and Lean Manufacturing
• Experience with statistical techniques and engineering problem-solving
• Experience with process/equipment validation
• Ability to read and interpret engineering drawings
• Strong documentation, communication, and leadership skills
• Experience working in a regulated manufacturing environment

Preferred

• ASQ Certified Quality Engineer (CQE)
• Six Sigma Green Belt or higher
• Medical device manufacturing experience
• Automation, software testing, or software validation experience
• Experience with GMP / Quality Systems / cleanroom manufacturing