QA Technician – Medical Device Quality & Compliance

Zvh; Batesville (IN); Híbrido; USD 43 000 - 59 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

401(k) Retirement Savings Plan

Employee Stock Purchase Plan (ESPP)

Paid time off

Parental leave

Resumo da oferta

Baxter in Batesville, IN is seeking a QA Technician to support quality and regulatory work behind medical bed devices. You will ensure products meet FDA requirements and Baxter policies, maintain quality records, and collaborate with Manufacturing and Engineering to sustain compliance in a team‑oriented environment.

The role emphasizes accuracy, attention to detail, and hands‑on quality support across the production process. Strong documentation and regulatory knowledge are essential.

Qualificações

• High school diploma or GED or above.
• 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.
• Applicants must be authorized to work for an employer in the U.S.
• We are unable to sponsor or take over sponsorship of an employment visa at this time.

Responsabilidades

• 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.

Conhecimentos

Attention to detail

Strong organizational skills

Excellent documentation

Strong computer skills

Formação académica

High school diploma or GED

2-year technical degree or equivalent

Ferramentas

Document Control System

Descrição da oferta de emprego

Baxter in Batesville, IN is seeking a QA Technician to support quality and regulatory work behind medical bed devices. You will ensure products meet FDA requirements and Baxter policies, maintain quality records, and collaborate with Manufacturing and Engineering to sustain compliance in a team‑oriented environment.

The role emphasizes accuracy, attention to detail, and hands‑on quality support across the production process. Strong documentation and regulatory knowledge are essential.