Quality Assurance Lead: Customer Complaints & CAPA

Automatic Data Processing, Inc.; Fishers (IN); On-site; USD 55,000 - 85,000; Full time

Job summary

Automatic Data Processing, Inc. in Fishers, IN seeks a Quality Assurance Specialist to lead timely customer complaints investigations and ensure compliant, thorough documentation. You will coordinate root cause analyses and support corrective actions to prevent recurrence.

The role requires experience in a regulated manufacturing environment, familiarity with CFR 21 CFR Part 820, ISO 13485/9001, and the ability to read engineering drawings. 3–5 years of relevant experience is expected.

Qualifications

• Associate degree or higher or GED with equivalent experience or training required.
• 3–5 years of manufacturing experience in a regulated industry required.
• Experience in visual and dimensional evaluation of molded products preferred, and knowledge of quality systems.

Responsibilities

• Lead timely customer complaint investigations and ensure uniform processing.
• Enter Customer Complaints into IQMS CAR module and report trends to management.
• Coordinate root cause analysis with SMEs and support corrective actions.
• Review device history records and manufacturing records for evidence.
• Read and interpret engineering drawings and inspection documents.
• Develop and maintain KPIs and dashboards for departmental goals.
• Support final lot history review and issuance of CoCs for shipments.
• Follow safety guidelines and assist cross functional teams.

Skills

Attention to detail

Communication skills

Read engineering drawings

Root cause analysis

Team collaboration

Education

Associate’s degree or High School Diploma or GED with equivalent experience/training

Tools

Windows

Word

Excel

Job description

Automatic Data Processing, Inc. in Fishers, IN seeks a Quality Assurance Specialist to lead timely customer complaints investigations and ensure compliant, thorough documentation. You will coordinate root cause analyses and support corrective actions to prevent recurrence.

The role requires experience in a regulated manufacturing environment, familiarity with CFR 21 CFR Part 820, ISO 13485/9001, and the ability to read engineering drawings. 3–5 years of relevant experience is expected.