Quality Engineer — Medical Device QMS & CAPA Expert

Barry-Wehmiller Companies Inc.; Tucson (AZ); Vor Ort; USD 85.000 - 115.000; Vollzeit

Zusammenfassung

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

You will own CAPA, document change control, calibration programs, and supplier quality while partnering with Production, Engineering, Supply Chain, and Quality. The role emphasizes proactive quality engineering—data-driven problem solving, risk management, and process controls to prevent issues rather than relying on inspection.

Qualifikationen

• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field (or equivalent).
• 3+ years of quality engineering in a regulated manufacturing environment.
• Experience with QMS, including document/change control and calibration/measurement equipment control.
• CAPA, root-cause analysis, and nonconformance/risk management proficiency.
• Familiarity with ISO 13485, FDA QSR (21 CFR 820), and ISO 14971 is preferred.

Aufgaben

• Own and administer quality system processes, including CAPA and change control.
• Support calibration programs for inspection and test equipment.
• Lead or support NCR, CAPA, RCA investigations with structured tools.
• Analyze defects and data to improve first-pass yield and supplier quality.

Kenntnisse

Quality engineering

Root cause analysis

Analytical skills

Documentation control

Ausbildung

Bachelor’s degree in Engineering/Quality/Manufacturing

Tools

MasterControl

ETQ

M1

Infor LN

Minitab

Jobbeschreibung

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

You will own CAPA, document change control, calibration programs, and supplier quality while partnering with Production, Engineering, Supply Chain, and Quality. The role emphasizes proactive quality engineering—data-driven problem solving, risk management, and process controls to prevent issues rather than relying on inspection.