QA Technician, Medical Devices - FDA/ISO Compliance

Baxter Healthcare; Batesville (IN); Sur place; USD 43 000 - 59 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage

ESPP (Employee Stock Purchase Plan)

401(k) with company matching

Paid time off 20–35 days

Family and medical leaves of absence

Parental leave

Résumé du poste

As a Quality Assurance (QA) Technician at Baxter’s Batesville site, you will support quality and regulatory work behind medical bed devices. You’ll collaborate with Manufacturing and Document Control to ensure products meet quality standards and FDA requirements, while maintaining accurate quality records in a patient-focused, regulated environment.

You will join a Quality Assurance and Regulatory Affairs team, providing hands-on quality support throughout production and contributing to

Qualifications

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

Responsabilités

• 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.

Connaissances

Attention to detail

Organizational skills

Documentation skills

Computer skills

FDA/ISO knowledge

Formation

High school diploma or GED

2-year technical degree or equivalent

Description du poste

As a Quality Assurance (QA) Technician at Baxter’s Batesville site, you will support quality and regulatory work behind medical bed devices. You’ll collaborate with Manufacturing and Document Control to ensure products meet quality standards and FDA requirements, while maintaining accurate quality records in a patient-focused, regulated environment.

You will join a Quality Assurance and Regulatory Affairs team, providing hands-on quality support throughout production and contributing to