Quality Engineer - QA, CAPA & Compliance (Med Devices)

AirLife; Grand Rapids (MI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k)

Paid time off

Holidays & leave

Job summary

AirLife seeks a Quality Engineer to ensure product quality and regulatory compliance across the lifecycle. You will work with Purchasing, Suppliers, Incoming Inspection, Production, Engineering, and Customers to verify and validate products, manage risk, and drive corrective actions.

Experience with quality systems, CAPA, and post-market feedback is preferred; travel 10–15%. The role emphasizes continuous improvement and cross-functional teamwork within AirLife's manufacturing environment.

Qualifications

• Experience with AQL inspections, control plans, and interpreting drawings.
• Design controls and risk management for verification/validation; knowledge of statistics.
• Familiarity with ISO 13485 and CAPA processes.
• Strong root-cause analysis and corrective action skills.

Responsibilities

• Support day-to-day product design quality activities compliant with AirLife processes.
• Assist pre/post-production design assurance and quality engineering during lifecycle.
• Support engineering feasibility testing and analysis.
• Investigate nonconformances and customer complaints.
• Initiate CAPAs and track corrective actions.
• Support quality system audits and ISO 13485 compliance.

Skills

AQL inspection

Design controls

ISO 13485

CAPA

Root cause analysis

Post-market feedback

Mechanical concepts

Defective products analysis

Analytical problem solving

KPI driven

MS Office

Education

Bachelor in engineering (mechanical/biomedical/industrial/manufacturing)

ASQ certification

Job description

AirLife seeks a Quality Engineer to ensure product quality and regulatory compliance across the lifecycle. You will work with Purchasing, Suppliers, Incoming Inspection, Production, Engineering, and Customers to verify and validate products, manage risk, and drive corrective actions.

Experience with quality systems, CAPA, and post-market feedback is preferred; travel 10–15%. The role emphasizes continuous improvement and cross-functional teamwork within AirLife's manufacturing environment.