Quality Engineer - CAPA & Data-Driven Improvements

American Orthodontics; Sheboygan (WI); Hybrid; USD 70,000 - 100,000; Full time

Job summary

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

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.
• Ability to work independently and lead others to task completion.
• Strong verbal and written communication skills.

Responsibilities

• 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.

Skills

CAPA leadership

Root cause analysis

Data-driven decision making

Cross-functional coordination

Effective communication

Education

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

Job description

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