Quality Engineer

American Orthodontics•Sheboygan, WI

13d

About The Position

The Quality Engineer leads investigations of quality issues, including internal nonconformities and customer complaints, and owns the Corrective and Preventative Action (CAPA) process. The role analyzes quality data, communicates trends, and supports product and process improvement through effective inspection methods and data-driven systems. It also supports new product development, audits, and process verification and validation, while providing quality guidance to engineers, technicians, and cross-functional teams.

Requirements

Bachelor of Science degree in Engineering, Quality, or a related field.
3–5 years of experience.
Ability to work and make decisions independently and lead others in completing assigned tasks.
Effective verbal and written communication skills.
Ability to sit, stand, and/or walk for up to 8–10 hours per day.
Ability to occasionally lift up to 25 pounds.
Availability for occasional early morning or late evening teleconferences.
Ability to make occasional visits to suppliers.

Nice To Haves

Experience with medical devices or other highly regulated industries or products.

Responsibilities

Lead investigations of internal nonconformities and customer complaints.
Manage CAPA activities, including root cause analysis, solution identification, implementation, and effectiveness verification.
Own and improve the CAPA process, including its effectiveness, efficiency, and cross-functional coordination.
Analyze quality data, communicate trends to cross-functional teams, and identify opportunities for product and process improvement.
Develop and implement measurement and inspection methods.
Establish systems for data collection, management, and monitoring to support data-driven decision-making and problem-solving.
Support new product development by defining inspection processes and providing training to meet product quality, performance, and regulatory compliance requirements.
Collaborate with engineering and production teams to establish sampling plans for evaluating product and process quality.
Participate in internal and external audits and determine corrective and preventative actions for audit findings.
Support process verification and validation, including developing and executing IQ, OQ, and PQ protocols and reports.
Provide technical guidance on quality principles, best practices, and problem-solving methodologies to engineers, technicians, and cross-functional teams.
Perform additional responsibilities as requested to achieve business objectives.