Principal Quality Systems Engineer - Aerospace

Principal Quality Systems Engineer - Aerospace

Fort Wayne, IN, USA

Job Description

Posted Friday, October 3, 2025 at 4 : 00 AM

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer's quality specifications for each product we produce.

The Principal Quality Systems Engineer will lead the development, implementation, and continuous improvement of the Quality Management System (QMS) to meet AS9100 certification requirements. This role is critical in augmenting the current ISO 13485 : 2016 to meet AS9100 standards, ensuring compliance with aerospace, defense, and space industry regulations

What You'll Do :

• Lead gap analysis and implementation planning for AS9100D certification.
• Develop and revise QMS documentation including procedures for configuration management, counterfeit part prevention, FOD control, and product safety. [Aerospace Entry]
• Host internal audits and support third-party audits from AS9100 registrars and customers.
• Participate in CAPA and complaint handling processes.
• Generate and analyze quality system metrics (e.g., CAPAs, audits, complaints).
• Lead cross-functional teams in quality system upgrades and continuous improvement initiatives.
• Oversee supplier quality processes including flow-down of customer requirements and supplier performance monitoring.
• Train internal teams on AS9100 clauses, human factors, and aerospace-specific quality controls.
• Maintain technical files, DMRs, DHFs, and validation packages.
• Act as the primary quality contact for aerospace customers.
• Ensure compliance with FDA, ISO 13485, ISO 9001, and AS9100 standards.
• Collaborates with cross-functional colleagues to ensure achievement of standards and regulations
• Other duties may be assigned.

What You'll Need :

What You Won't Do :

Who You Are :

What You'll Enjoy :

Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

J-18808-Ljbffr