Quality Assurance Specialist – QA Systems & Compliance

About the role

The Quality Assurance Specialist will support site QA activities within Abbott Rapid Diagnostics' CMI Business Unit. The role focuses on maintaining and improving key quality subsystems such as document control, training, complaints, non‑conformances, CAPA and supplier control.

Key responsibilities

• Implement and maintain the effectiveness of the Quality System.
• Participate in CAPA, equipment maintenance, product and process planning, quality audits and validation activities.
• Manage complaints, change requests, NCMRs, deviations and support regulatory audits.
• Maintain quality metrics, document control and supplier surveys.
• Coordinate training programs and ensure compliance with training requirements.
• Assist with equipment calibration, qualification and validation of processes and facilities.
• Identify risks, drive functional performance and ensure cross‑functional standards are met.

Required profile

• Strong understanding of quality system processes and regulatory compliance.
• Ability to conduct investigations, risk assessments and implement corrective actions.
• Professional behavior with internal and external stakeholders.
• Attention to detail in documentation and adherence to company policies.

Required skills

• CAPA management
• Document control
• Quality audits and regulatory audits
• Equipment calibration and maintenance
• Supplier survey review

What we offer

• Opportunity to work with industry‑leading diagnostic technologies.
• Collaborative environment within a global healthcare company.
• Professional development and continuous improvement initiatives.