Lead QA Auditor: Batch Records & Compliance

ICU Medical, Inc.; Southington (CT); On-site; USD 55,000 - 75,000; Full time

Job summary

ICU Medical, Inc. is seeking a Final Quality Assurance professional to audit batch records for completeness and regulatory compliance before final product release. You will perform audits in both hard copy or electronic formats and retain batch records per retention procedures.

The role supports manufacturing quality and risk detection, working with various teams to ensure records meet FDA, ISO, and company policy requirements. Travel and shifting may be involved.

Qualifications

• Excellent mathematical knowledge.
• Good knowledge in records filing.
• Good computer knowledge.
• Ability to comprehend both verbal and written instructions.

Responsibilities

• Perform audits on each batch record to ensure completion and compliance.
• Execute final product release via iFactory / Oracle system.
• Access to Oracle Installed Base to update serial device information.
• Provide Manufacturing / MQA support to detect quality risks.
• Verify that the records documented are within the corresponding procedures.
• Demonstrate leadership, problem solving skills and technical knowledge with strong communication.

Skills

Mathematical knowledge

Records filing

Computer literacy

Verbal & written communication

Education

High School Diploma or GED

Tools

Oracle

iFactory

Job description

ICU Medical, Inc. is seeking a Final Quality Assurance professional to audit batch records for completeness and regulatory compliance before final product release. You will perform audits in both hard copy or electronic formats and retain batch records per retention procedures.

The role supports manufacturing quality and risk detection, working with various teams to ensure records meet FDA, ISO, and company policy requirements. Travel and shifting may be involved.