Quality Assurance Technician – Medical Devices

Baxter International Inc.; Batesville (AL); In loco; USD 43.000 - 59.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical coverage

Dental coverage

ESPP

401(k) matching

Paid time off 20–35 days

Descrizione del lavoro

Baxter International Inc. in Batesville is seeking a QA Technician to support quality and regulatory work behind medical bed devices. You will ensure Device History Records are complete, participate in audits, and provide training to ensure GDP compliance.

You will collaborate with Manufacturing, Engineering, and Document Control to maintain compliance and drive continuous improvement. This role requires attention to detail, knowledge of FDA/ISO standards, and strong documentation skills.

Competenze

• Must have knowledge of FDA and ISO standards.
• Strong organizational and documentation skills.
• Strong computer skills.
• Demonstrated high attention to detail.

Mansioni

• 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.

Conoscenze

FDA/ISO standards

Organizational/documentation

Computer skills

Attention to detail

Formazione

High school diploma or GED

2-year technical degree or equivalent experience

Descrizione del lavoro

Baxter International Inc. in Batesville is seeking a QA Technician to support quality and regulatory work behind medical bed devices. You will ensure Device History Records are complete, participate in audits, and provide training to ensure GDP compliance.

You will collaborate with Manufacturing, Engineering, and Document Control to maintain compliance and drive continuous improvement. This role requires attention to detail, knowledge of FDA/ISO standards, and strong documentation skills.