Quality Engineer – Medical Devices (Design, Risk, CAPA)

AirLife; Michigan; On-site; USD 70,000 - 100,000; Full time

Job summary

AirLife is hiring a Quality Engineer to safeguard product quality across design through post-market stages. You will support cross-functional teams in purchasing, production, engineering, and customers with a focus on verification, validation, and risk management.

This role emphasizes CAPA initiation, root-cause analysis, and continuous quality improvements while ensuring compliance with applicable standards and design controls throughout the product lifecycle.

Qualifications

• Experience with AQL inspections, control plans, and drawings interpretation.
• Design controls, risk management, test methods validation, and statistics.
• Familiarity with ISO 13485 and CAPA processes.
• Root cause analysis and problem solving required.
• Strong technical writing and cross-functional collaboration.
• Exposure to FDA/medical device manufacturing is a plus.

Responsibilities

• Support day-to-day product design quality activities and ensure compliance.
• Assist pre/post-production quality engineering for lifecycle development.
• Support validation for tooling, transfers, and new product introductions.
• Investigate nonconformances and customer complaints.
• Initiate and manage CAPAs; drive continuous improvement.
• Interpret specs for production and incoming inspection; assess risk.

Skills

AQL inspection

Design Controls

Risk Management

ISO 13485

Root Cause Analysis

CAPA

Post Market Feedback

Statistical methods

Quality writing

Cross-functional work

Documentation

Analytical thinking

MS Office

Education

B.S. Mechanical/Biomedical/Industrial/Manufacturing Eng

ASQ certification

Tools

Microsoft Office Suite

Job description

AirLife is hiring a Quality Engineer to safeguard product quality across design through post-market stages. You will support cross-functional teams in purchasing, production, engineering, and customers with a focus on verification, validation, and risk management.

This role emphasizes CAPA initiation, root-cause analysis, and continuous quality improvements while ensuring compliance with applicable standards and design controls throughout the product lifecycle.