Principal Quality Systems Engineer - Aerospace
Avalign Technologies.com
Office
Fort Wayne, IN, US
Full Time
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:
• Bachelor’s degree in Engineering, Quality, or related field.
• Minimum 5–8 years of experience in quality systems within aerospace industry.
• Strong knowledge of AS9100D and risk management tools (FMEA, fault tree).
• ASQ CQE, Six Sigma, or Lean certifications preferred.
• Experience with QMS software, statistical analysis tools, and audit managementplatforms.
• Strategic thinking and project management.
• Strong communication and leadership skills.
• Ability to lead cross-functional teams and drive change.
• Detail-oriented with a proactive approach to problem-solving.
• Ability to listen effectively and utilize various modes to communicate with employees at all levels
• Possesses a proficient written and technical communication skillset
• Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions and follows through on commitments.
• Demonstrates accuracy and thoroughness to improve and promote quality; Applies feedback to improve performance; and monitors own work to ensure quality.
What You Won’t Do:
• Feel stuck – we offer great opportunities to advance and learn
• Get bored – we make a high variety of products, so no day is the same
• Feel like a number – we’re a close-knit bunch and always have each other’s backs
Who You Are:
• A self-starter who thrives in a fast-paced environment
• A quick learner who is always ready to gain depth of knowledge in manufacturing processes
• A reliable individual who knows the importance of showing up when it counts
• Someone who accept assignments with an open, cooperative, positive and team-oriented approach
• Someone who is able to plan and execute plans across teams
• An effective communicator, both written and verbal
What You’ll Enjoy:
• Competitive compensation and benefits package
• Comprehensive medical, dental, and vision insurance
• Paid vacation and 10 observed paid holidays per year
• Employer funded Basic Life and AD&D insurance
• Employer funded STD and LTD insurance
• Tuition reimbursement
• Great 401(k) with company match
• Generous employee referral bonus program
• Working for a thriving, performance-based company that values promoting from within and career advancement
• Temperature controlled environment
• Community involvement investing and giving back to the community
• Additional free resources such as travel assistance, EAP, etc.
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.
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:
• Bachelor’s degree in Engineering, Quality, or related field.
• Minimum 5–8 years of experience in quality systems within aerospace industry.
• Strong knowledge of AS9100D and risk management tools (FMEA, fault tree).
• ASQ CQE, Six Sigma, or Lean certifications preferred.
• Experience with QMS software, statistical analysis tools, and audit managementplatforms.
• Strategic thinking and project management.
• Strong communication and leadership skills.
• Ability to lead cross-functional teams and drive change.
• Detail-oriented with a proactive approach to problem-solving.
• Ability to listen effectively and utilize various modes to communicate with employees at all levels
• Possesses a proficient written and technical communication skillset
• Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions and follows through on commitments.
• Demonstrates accuracy and thoroughness to improve and promote quality; Applies feedback to improve performance; and monitors own work to ensure quality.
What You Won’t Do:
• Feel stuck – we offer great opportunities to advance and learn
• Get bored – we make a high variety of products, so no day is the same
• Feel like a number – we’re a close-knit bunch and always have each other’s backs
Who You Are:
• A self-starter who thrives in a fast-paced environment
• A quick learner who is always ready to gain depth of knowledge in manufacturing processes
• A reliable individual who knows the importance of showing up when it counts
• Someone who accept assignments with an open, cooperative, positive and team-oriented approach
• Someone who is able to plan and execute plans across teams
• An effective communicator, both written and verbal
What You’ll Enjoy:
• Competitive compensation and benefits package
• Comprehensive medical, dental, and vision insurance
• Paid vacation and 10 observed paid holidays per year
• Employer funded Basic Life and AD&D insurance
• Employer funded STD and LTD insurance
• Tuition reimbursement
• Great 401(k) with company match
• Generous employee referral bonus program
• Working for a thriving, performance-based company that values promoting from within and career advancement
• Temperature controlled environment
• Community involvement investing and giving back to the community
• Additional free resources such as travel assistance, EAP, etc.
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.
Principal Quality Systems Engineer - Aerospace
Office
Fort Wayne, IN, US
Full Time
October 3, 2025