Quality Assurance Technician – Medical Devices

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

Job summary

Baxter International Inc. located in Batesville, IN, is seeking a QA Technician to support quality and regulatory work behind medical bed devices. You will work with Manufacturing and other teams to ensure products meet quality, FDA, and Baxter policies.

Responsibilities include maintaining Device History Records, supporting GDP practices, and performing audits. Candidates should have a HS diploma, technical degree or equivalent, and strong documentation and computer skills.

Qualifications

• High school diploma or GED.
• 2-year technical degree or equivalent work experience preferred.
• 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 NCMR's 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

Attention to detail

Organizational skills

Documentation skills

Computers

Education

High school diploma or GED

2-year technical degree or equivalent

Job description

Baxter International Inc. located in Batesville, IN, is seeking a QA Technician to support quality and regulatory work behind medical bed devices. You will work with Manufacturing and other teams to ensure products meet quality, FDA, and Baxter policies.

Responsibilities include maintaining Device History Records, supporting GDP practices, and performing audits. Candidates should have a HS diploma, technical degree or equivalent, and strong documentation and computer skills.