Quality Engineer

American Orthodontics; Sheboygan (WI); Híbrido; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

American Orthodontics is seeking a Quality Assurance professional to lead CAPA activities, investigate quality issues, and drive cross-functional improvements. The role emphasizes root cause analysis, data-driven decisions, and collaboration with engineering and production to enhance product quality.

The ideal candidate will have a BS in Engineering/Quality with 3–5 years in regulated environments, strong communication skills, and the ability to work independently while guiding teams to

Formación

• BS degree in Engineering, Quality, or a related field with 3–5 years of experience.
• Experience with medical devices or other highly regulated industries/products desired.
• Ability to work independently and lead others to task completion.
• Strong verbal and written communication skills.

Responsabilidades

• Lead investigations of quality issues, including internal nonconformities and customer complaints.
• Manage CAPA activities with root cause analysis, solution identification, implementation, and verification.
• Own CAPA process and improve its effectiveness, efficiency, and cross-functional coordination.
• Analyze quality data, communicate trends to cross-functional teams, and identify improvement opportunities.
• Develop and implement measurement and inspection methods; support data collection and monitoring for decision-making.
• Support new product development by defining inspection processes and providing training for quality assurance.
• Collaborate with engineering and production to establish sampling plans for product and process quality.
• Participate in internal and external audits; determine corrective and preventative actions for audit findings.
• Support IQ, OQ, and PQ protocols and reports for process verification and validation.
• Provide technical guidance to engineers, technicians, and cross-functional teams on quality principles and problem-solving.

Conocimientos

CAPA leadership

Root cause analysis

Data-driven decision making

Cross-functional coordination

Effective communication

Educación

Bachelor's degree in Engineering, Quality, or related field

Descripción del empleo

Responsibilities

• Lead investigations of quality issues, including internal nonconformities and customer complaints. Manage Corrective and Preventative Action (CAPA) activities, including root cause analysis, solution identification, implementation, and effectiveness verification.
• Own the CAPA process and identify opportunities to improve 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 effective 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 activities by defining inspection processes and providing training to ensure product quality, performance, and regulatory compliance requirements are met.
• Collaborate with engineering and production teams to establish appropriate sampling plans for evaluating product and process quality.
• Participate in internal and external audits; determine appropriate corrective and preventative actions to address audit findings
• Support process verification and validation activities, including the development and execution of IQ, OQ, and PQ protocols and reports.
• Provide technical guidance to engineers, technicians, and cross-functional teams on quality principles, best practices, and problem-solving methodologies.
• Perform additional responsibilities as requested to achieve business objectives

Qualifications

• BS degree in Engineering, Quality, or a related field, with 3-5 years of experience
• Experience with medical devices or other highly regulated industries/products desired
• Demonstrated ability to work and make decisions independently and lead others to the completion of assigned tasks
• Demonstrated ability to communicate effectively both verbally and in written form

Physical Requirements:

• Must be able to sit, stand, and/or walk for up to 8-10 hours per day
• Must be able to occasionally lift up to 25 pounds
• May require occasional early morning or late evening teleconferences
• May require occasional visits to suppliers

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.