Senior Quality Engineer Injection Molding - Medical Devices

Straffing AI; Brooklyn Park (MN); On-site; USD 91,000 - 130,000; Full time

Job summary

Strafing AI in Brooklyn Park, MN is seeking a Senior Quality Engineer to drive manufacturing quality in a highly regulated medical-device environment. This hands-on role covers production support, process improvement, validation, inspection, CAPA, and quality systems.

You will lead PFMEA, control plans, audits, and mentor junior engineers, collaborating with Manufacturing, Engineering, and Quality teams. Experience in injection molding and ISO 13485 / FDA-regulated settings is highly valued;

Qualifications

• We are seeking candidates with hands-on quality engineering in manufacturing environments.
• Strong knowledge of PFMEA, CAPA, root-cause analysis, and statistical methods.
• Experience with metrology, inspection plans, and quality documentation is essential.

Responsibilities

• Provide quality engineering support to manufacturing and cross-functional project teams.
• Develop and maintain inspection plans, control plans, quality documentation, and manufacturing quality requirements.
• Facilitate PFMEA activities and manufacturing risk assessments.
• Investigate nonconforming material and drive CAPA and trend analysis.
• Support customer complaint investigations, root-cause analysis, and audit closures.
• Apply DOE, SPC, and data analysis to identify process improvements.
• Support validation activities for processes, equipment, and metrology.

Skills

PFMEA

CAPA

DOE

SPC

Root-cause analysis

Data analysis

Education

Bachelor’s in Mechanical Engineering

Tools

Minitab

ERP systems

Job description

Strafing AI in Brooklyn Park, MN is seeking a Senior Quality Engineer to drive manufacturing quality in a highly regulated medical-device environment. This hands-on role covers production support, process improvement, validation, inspection, CAPA, and quality systems.

You will lead PFMEA, control plans, audits, and mentor junior engineers, collaborating with Manufacturing, Engineering, and Quality teams. Experience in injection molding and ISO 13485 / FDA-regulated settings is highly valued;