Quality Engineer, Medical Devices & QMS Lead

Machine Solutions Inc.; Tucson (AZ); Sur place; USD 85 000 - 110 000; Plein temps

Résumé du poste

Machine Solutions, Inc. seeks a Quality Engineer to support product, process, and quality system performance in a regulated medical device environment.

You will own key QMS processes, including document control, calibration, CAPA, and supplier quality, while partnering with Production, Engineering, Supply Chain, and Quality to resolve issues and drive improvements. The role emphasizes proactive quality engineering using data and risk management, with audits and customer documentation support.

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, or related field.
• 3+ years of quality engineering in regulated manufacturing.
• Experience with QMS, document/change control, and calibration/measurement equipment control.
• Strong analytical and communication skills; ability to read drawings and specs.
• Preferred: ISO 13485, FDA QSR, ISO 14971 familiarity.

Responsabilités

• Provide day‑to‑day quality engineering support to manufacturing and engineering teams.
• Lead or support NCR, CAPA, and RCA investigations with structured tools.
• Analyze defects, nonconformances, scrap, and rework data to identify trends.
• Support supplier quality, audits, and documentation for regulatory compliance.
• Contribute to risk management, process controls, and continuous improvement.

Connaissances

Quality engineering

Root cause analysis

CAPA

Analytical skills

Formation

Bachelor's degree in Engineering/Quality/Manufacturing

Outils

MasterControl

ETQ

M1

Infor LN

Minitab

Description du poste

Machine Solutions, Inc. seeks a Quality Engineer to support product, process, and quality system performance in a regulated medical device environment.

You will own key QMS processes, including document control, calibration, CAPA, and supplier quality, while partnering with Production, Engineering, Supply Chain, and Quality to resolve issues and drive improvements. The role emphasizes proactive quality engineering using data and risk management, with audits and customer documentation support.