Quality Assurance Executive

About the role

The Quality Assurance Executive supports the Quality Assurance Lead in executing QA activities according to the Quality Management System, ISO 13485, FDA requirements and internal procedures.

Key responsibilities

• Execute QA tasks following approved SOPs, work instructions and regulatory standards.
• Maintain QA documentation, controlled records and ensure data integrity and traceability.
• Prepare and update SOPs, forms and other controlled QA documents.
• Carry out validation, qualification, re‑qualification and change‑control activities, including IQ/OQ/PQ/CSV.
• Support internal and external audits, providing documentation and evidence.
• Assist with CAPA, non‑conformity investigations, root‑cause analysis and corrective actions.
• Monitor manufacturing and distribution for compliance and report deviations.
• Support supplier quality activities, maintaining records and tracking issues.

Required profile

• Bachelor’s degree in Pharmacy, Engineering, Chemistry, Biology or a related scientific field.
• 0–2 years of experience in Quality Assurance or Quality Management.
• Experience in a regulated environment such as medical devices, pharmaceuticals or biotechnology is preferred.
• Strong attention to detail and ability to maintain accurate quality documentation.

Required skills

• Knowledge of ISO 13485 and FDA Quality System requirements.
• Hands‑on experience with validation and qualification (IQ/OQ/PQ/CSV).
• Understanding of CAPA and non‑conformity management.
• Familiarity with internal auditing and supplier quality processes.

What we offer

• Great culture and growth opportunities.
• Ability to impact customer experience directly.
• Work with highly motivated, cross‑functional teams.