Senior Quality Engineer – Medical Devices

Industry: Medical Devices / MedTech Manufacturing

Position Overview

We are seeking 2 Senior Quality Engineers to support the Utah Plastics manufacturing facility of a well-established MedTech Contract Development and Manufacturing Organization (CDMO). The ideal candidates will have strong experience in manufacturing quality, CAPA, root cause analysis, process controls, and continuous quality improvement within FDA- and ISO 13485-regulated environments.

Key Responsibilities

• Lead Root Cause Analysis (RCA), CAPA, and preventive action activities for manufacturing quality issues.
• Identify recurring defects and implement sustainable corrective and preventive solutions.
• Develop and improve process controls, process capability, and defect prevention strategies.
• Analyze quality issues related to plastics, injection molding, assembly, and labeling processes.
• Utilize Minitab for statistical analysis, SPC, process capability studies, and quality investigations.
• Develop and maintain PFMEA, Control Plans, SPC, and other quality documentation.
• Partner with Quality, Manufacturing, Operations, and Engineering teams to resolve production issues.
• Drive continuous improvement initiatives to reduce defects, improve process capability, and prevent recurrence.
• Support compliance with FDA regulations and ISO 13485 quality-system requirements.
• Work independently on quality investigations and provide technical recommendations to manufacturing teams.

Required Skills

• 6–12 years of experience in Quality Engineering / Manufacturing Quality.
• Strong experience in Medical Device manufacturing.
• Hands-on experience with RCA, CAPA, 8D, corrective/preventive actions, and defect prevention.
• Experience with SPC, process capability analysis, statistical methods, and Minitab.
• Strong knowledge of PFMEA, Control Plans, process controls, and continuous improvement.
• Experience with plastics manufacturing and injection molding is highly preferred.
• Experience supporting assembly and labeling quality processes.
• Strong understanding of FDA-regulated and ISO 13485 manufacturing environments.
• Excellent problem-solving, analytical, documentation, and cross-functional communication skills.

Preferred Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, Mechanical, Industrial, or related field.
• Experience working directly with manufacturing and operations teams in a regulated environment.
• Ability to independently lead investigations and drive quality improvements from identification through implementation.
• Experience transitioning manual/paper-based quality processes toward more structured and sustainable preventive-action practices.