Quality Assurance Technician: Medical Devices & Compliance

Baxter International Inc.; Batesville (IN); On-site; USD 43,000 - 59,000; Full time

Benefits offered by this job

Medical and dental coverage

Life insurance

Short-term disability

401(k) with company match

Employee stock purchase plan (ESPP)

Job summary

Baxter International Inc. in Batesville, IN is seeking a Quality Assurance Technician to uphold device history records, support FDA/ISO compliance, and collaborate with Manufacturing and Document Control to ensure products meet quality standards.

You will train staff, perform audits, and contribute to continuous improvement in a regulated, patient-focused environment. Education requirements include a high school diploma or GED, with a 2-year technical degree preferred.

Qualifications

• Knowledge of FDA and ISO standards.
• Strong organizational/documentation skills.
• Strong computer skills.
• Demonstrated high attention to detail.

Responsibilities

• Ensure the Device History Records (DHR) are properly and accurately completed.
• Serve as a primary point of contact for rapid and effective corrections of quality issues identified with the Device History Records.
• Provide training to ensure proper completion and accurate GDP used with the Device History Records.
• Ensure the NCMRs have been properly documented prior to release of the product for distribution.
• Release the product for distribution by properly signing the Device History Record.
• Complete the required documentation for properly entering the Device History Records in the Document Control System.
• Perform audits to include testing and visual inspection of products.
• Capable of performing non-routine or complex tasks.
• Observes, records, and analyzes data to maintain daily audit reports.
• May require developing new procedures.

Skills

FDA/ISO standards

Documentation

Computer skills

Attention to detail

Education

High school diploma or GED

2-year technical degree

Job description

Baxter International Inc. in Batesville, IN is seeking a Quality Assurance Technician to uphold device history records, support FDA/ISO compliance, and collaborate with Manufacturing and Document Control to ensure products meet quality standards.

You will train staff, perform audits, and contribute to continuous improvement in a regulated, patient-focused environment. Education requirements include a high school diploma or GED, with a 2-year technical degree preferred.