Senior Quality Analyst/Engineer

Infosys Pontoon • Salt Lake City, UT

1d • Hybrid

About The Position

The Senior Quality Analyst/Engineer will work in a medical device manufacturing environment in Salt Lake City, Utah, with a hybrid work arrangement. This senior-level role requires independently partnering with quality, manufacturing, and operations teams. The position focuses on medical device quality engineering and manufacturing quality in FDA- and ISO 13485-regulated environments, including root cause analysis and corrective and preventive actions (CAPA).

Requirements

• Bachelor’s or master’s degree.
• 6–12 years of experience.
• Experience with medical devices and medical device quality engineering.
• Experience in manufacturing quality.
• Experience with root cause analysis and CAPA.
• Knowledge of SPC and process capability analysis.
• Knowledge of PFMEA and control plans.
• Experience with plastics manufacturing and injection molding.
• Experience with assembly and labeling processes.
• Experience in FDA- and ISO 13485-regulated manufacturing environments.
• Ability to operate independently with quality, manufacturing, and operations teams.

Responsibilities

• Operate independently with quality, manufacturing, and operations teams.
• Support quality engineering and manufacturing quality in medical device manufacturing.
• Perform root cause analysis and CAPA.
• Work with SPC and process capability analysis.
• Work with PFMEA and control plans.
• Support plastics manufacturing and injection molding.
• Support assembly and labeling processes.
• Operate in FDA- and ISO 13485-regulated manufacturing environments.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior