Quality Engineer, Medical Devices: QC & Compliance

Angel Aligner; Oak Creek (WI); On-site; USD 75,000 - 110,000; Full time

Job summary

Angel Aligner is seeking a Quality Engineer to ensure compliance with FDA QMSR 820 and ISO 13485 by performing inspections, testing, and data analysis. You will support manufacturing operations and quality functions, bridging hands-on execution with engineering solutions to uphold product quality and audit readiness.

The role includes handling NCR/CAPA, supplier audits, and continuous improvements across production and post-market activities.

Qualifications

• Strong documentation, communication, and analytical skills.
• Proficiency with measurement tools and inspection equipment.
• Experience in a regulated manufacturing environment—medical device preferred.
• Strong understanding of cGMP, ISO 13485, and QMSR 820.

Responsibilities

• Performs incoming, in-process, and final inspections using calipers, micrometers, gauges, vision systems, or other metrology tools.
• Responsible for daily product quality management on the production line, addressing issues to ensure high quality and customer satisfaction.
• Handle customer feedback and complaints; lead analysis and resolution; provide investigation results to HQ Post-market team within 24 hours.
• Support physical products with problem solving and usage instructions.
• Track post-market data, promote actions related to customer complaints, and collaborate on Field Corrective Actions.
• Audit suppliers and support HQ SQE teams in supplier management.
• Develop inspection and control documents and provide training and assessments.

Skills

Documentation & communication

Analytical skills

Cross-functional collaboration

Education

Associate or Bachelor’s degree in Engineering/Quality

Tools

Calipers

Micrometers

Gauges

Vision systems

Metrology tools

Job description

Angel Aligner is seeking a Quality Engineer to ensure compliance with FDA QMSR 820 and ISO 13485 by performing inspections, testing, and data analysis. You will support manufacturing operations and quality functions, bridging hands-on execution with engineering solutions to uphold product quality and audit readiness.

The role includes handling NCR/CAPA, supplier audits, and continuous improvements across production and post-market activities.