Quality Engineer – Med Device Validation Expert

Automatic Data Processing, Inc.; Fishers (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Automatic Data Processing, Inc. in Fishers, IN is seeking a Quality Engineer to support the Quality Management System, product realization, and manufacturing process controls.

You will define quality plans, lead validation activities, and collaborate with cross-functional teams to drive continuous improvement and regulatory compliance. The role emphasizes CAPA, audits, documentation control, and ensuring product quality across development and manufacturing stages.

Qualifications

• 3–5 years experience in Quality Assurance/Quality Engineering/Process Engineering in manufacturing.
• Bachelor's degree or equivalent in a technical field (engineering, materials science, data analytics, statistics, etc.).
• Strong communication skills across diverse audiences and ability to train technicians on quality standards.
• Excellent problem-solving abilities and analytical thinking.
• Strong project management skills with a results-driven approach.
• Risk-based thinking is applied to all quality decisions and processes.
• Proficient technical writing and documentation capabilities.

Responsibilities

• Monitor and report key quality metrics and trends.
• Lead investigations and CAPA activities to address deviations and customer complaints.
• Collaborate with cross-functional teams to drive process improvements.
• Support validation activities with R&D to ensure product quality and reliability.
• Ensure compliance with FDA/ISO 13485 requirements and internal procedures.
• Train staff in metrology, GD&T, and quality tools; participate in audits and inspections.

Skills

Quality engineering

Process engineering

Communication skills

Problem solving

Project management

Risk-based thinking

Technical writing

Education

Bachelor's degree or equivalent

Job description

Automatic Data Processing, Inc. in Fishers, IN is seeking a Quality Engineer to support the Quality Management System, product realization, and manufacturing process controls.

You will define quality plans, lead validation activities, and collaborate with cross-functional teams to drive continuous improvement and regulatory compliance. The role emphasizes CAPA, audits, documentation control, and ensuring product quality across development and manufacturing stages.