QMS Quality Associate II - CAPA, Audits & Batch Release

EKF Diagnostics USA (Stanbio Laboratory); South Bend (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

EKF Diagnostics USA (Stanbio Laboratory) is seeking a Quality Associate II to support the development and maintenance of their Quality Management System (QMS) in compliance with various regulations. You will oversee CAPA, audits, and training while ensuring documentation meets required standards.

The ideal candidate holds a Bachelor's degree in a science-related field and has three years of experience in quality related to medical devices. Strong knowledge of ISO standards is essential for success in this role.

Qualifications

• Three years of quality experience in relation to medical devices.
• Strong knowledge of ISO standards.
• Legally authorized to work in the United States.

Responsibilities

• Support development and maintenance of the Quality Management System (QMS).
• Administer and maintain QMS processes including CAPA and internal audits.
• Lead or support CAPA investigations with strong root-cause analysis.
• Review and approve batch records and final product documentation.
• Provide training on QMS and compliance requirements.

Skills

Attention to detail

Analytical skills

Project management

Communication skills

Education

Bachelor's degree in a science related field

Tools

Microsoft Word

Microsoft Excel

Training management system

Job description

EKF Diagnostics USA (Stanbio Laboratory) is seeking a Quality Associate II to support the development and maintenance of their Quality Management System (QMS) in compliance with various regulations. You will oversee CAPA, audits, and training while ensuring documentation meets required standards.

The ideal candidate holds a Bachelor's degree in a science-related field and has three years of experience in quality related to medical devices. Strong knowledge of ISO standards is essential for success in this role.