Senior Quality Engineer - Medical Devices & Compliance Leader

Avalign Technologies; Warsaw (IN); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Healthcare benefits

Tuition reimbursement

401(k) match

Paid vacation

Job summary

Avalign Technologies in Indiana is seeking a Quality Engineer to drive quality improvements across manufacturing and supplier processes. You will develop inspection plans, support validation activities for NPI transfers, and lead CAPA investigations to sustain product quality throughout the lifecycle.

The role requires a BS in engineering and at least 5 years of manufacturing experience, with knowledge of ISO 13485 and 21 CFR 820.

Qualifications

• BS in engineering science and at least 5 years of manufacturing experience.
• Understanding of ISO 13485 and 21 CFR 820 regulatory requirements.
• Ability to read blueprints, GD&T, and inspection methods.

Responsibilities

• Provide quality leadership in manufacturing inspection plan development.
• Lead validation planning for NPI transfer activities and assist teams in determining validation needs.
• Support CAPA investigations and drive continuous improvement across processes.

Skills

Quality leadership

Validation planning

CAPA investigations

Supplier management

Quality system

Risk management

Gage R&R

Statistical analysis

Process improvement

Education

BS in engineering science

Job description

Avalign Technologies in Indiana is seeking a Quality Engineer to drive quality improvements across manufacturing and supplier processes. You will develop inspection plans, support validation activities for NPI transfers, and lead CAPA investigations to sustain product quality throughout the lifecycle.

The role requires a BS in engineering and at least 5 years of manufacturing experience, with knowledge of ISO 13485 and 21 CFR 820.