Quality Engineer: Lead CAPA & Data-Driven Improvements

American Orthodontics Corp; Sheboygan (WI); Presencial; USD 80 000 - 110 000; Tempo integral

Resumo da oferta

American Orthodontics Corp seeks a QA professional to lead CAPA investigations, data analysis, and cross-functional improvement in a highly regulated medical device environment.

You will own CAPA processes, drive audits, and support product development with robust inspection standards and training. Strong leadership and communication are essential for success in this role at our Sheboygan, WI facility.

Qualificações

• BS degree in Engineering, Quality, or a related field.
• Experience in medical devices or other highly regulated industries is preferred.
• Demonstrated ability to work independently and lead others to task completion.
• Strong verbal and written communication skills.

Responsabilidades

• Lead quality investigations and CAPA activities including root cause analysis, solution identification, implementation and verification.
• Own CAPA process and drive cross-functional coordination and improvement.
• Analyze quality data and communicate trends to cross-functional teams for product and process improvements.
• Develop and implement measurement and inspection methods and data systems for data-driven decisions.
• Support new product development by defining inspection processes and providing training.
• Collaborate with engineering and production to establish sampling plans for quality evaluation.
• Participate in audits and determine corrective actions for findings.
• Support IQ/OQ/PQ protocols and reports.
• Provide technical guidance on quality principles and problem-solving methodologies.
• Perform additional responsibilities to achieve business objectives.

Conhecimentos

Leadership

Communication

Formação académica

BS in Engineering/Quality or related field

Descrição da oferta de emprego

American Orthodontics Corp seeks a QA professional to lead CAPA investigations, data analysis, and cross-functional improvement in a highly regulated medical device environment.

You will own CAPA processes, drive audits, and support product development with robust inspection standards and training. Strong leadership and communication are essential for success in this role at our Sheboygan, WI facility.