QA Specialist — Customer Complaints & Compliance

Stevanato Group; Fishers (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

Stevanato Group is seeking a Quality Assurance Specialist in Fishers, IN to lead timely customer complaint investigations and coordinate final lot history review. You will issue Certificates of Conformance to support customer shipments and ensure compliance with 21 CFR Part 820 and ISO 13485 standards.

The role requires strong documentation, investigation skills, and collaboration with cross-functional teams to implement corrective and preventive actions.

Qualifications

• Associate’s degree or equivalent experience is required.
• 3–5 years of manufacturing experience in a regulated environment preferred.
• 3–5 years in visual and dimensional evaluation of molded products or related processes.
• Experience with 21 CFR Part 820 and ISO 13485/9001 is preferred.
• Ability to understand safety requirements in a manufacturing setting.

Responsibilities

• Enter Customer Complaints into IQMS CAR module accurately.
• Investigate customer complaints and communicate findings weekly, monthly, and quarterly.
• Follow up with customers by phone or email to obtain information for investigations.
• Review device history records and manufacturing records to support investigations.
• Lead root cause analysis with SMEs and support corrective actions.
• Support other departments in the complaint resolution process.
• Inspect complaint products against retain samples and production specs.
• Read and interpret engineering drawings and inspection documents.

Skills

Root cause analysis

Data analysis

Communication skills

Attention to detail

Education

Associate’s degree or equivalent

Tools

IQMS CAR module

Calipers

Micrometers

Job description

Stevanato Group is seeking a Quality Assurance Specialist in Fishers, IN to lead timely customer complaint investigations and coordinate final lot history review. You will issue Certificates of Conformance to support customer shipments and ensure compliance with 21 CFR Part 820 and ISO 13485 standards.

The role requires strong documentation, investigation skills, and collaboration with cross-functional teams to implement corrective and preventive actions.