Quality Assurance Senior Associate

About the role

The Quality Assurance Senior Associate will support product quality assessments for medical devices by investigating technical complaints, evaluating returned samples, and ensuring compliance with regulatory standards.

Key responsibilities

• Execute, document, and follow up on technical complaint investigations for assigned products.
• Assess returned product samples (visual, dimensional, functional) and record findings.
• Review complaint data, assign initial risk classifications, and escalate complex cases.
• Coordinate complaint handling with Country Quality Units, third‑party partners, and cross‑functional teams.
• Monitor investigations against service level agreements, escalating delays or QMS deviations.
• Support deviation, CAPA, NCR, and other quality events through data collection, documentation, and action tracking.
• Conduct post‑market surveillance activities, trend analysis, and reporting.
• Perform QMS tasks such as document control, SOP updates, training administration, and record maintenance.
• Manage supplier quality documentation and follow‑up actions.
• Assist with audits, inspections, process transitions, and continuous‑improvement initiatives.

Required profile

• Advanced or completed engineering degree or comparable scientific/technical discipline.
• 2‑4 years experience in complaint handling, quality assurance, medical devices, pharmaceuticals, GMP, or a regulated industry.
• Proficiency in English and Spanish (minimum B2/C1), both written and spoken.
• Strong quality mindset and attention to detail.

Required skills

• Complaint handling
• Quality Assurance
• Good Manufacturing Practice (GMP)
• CAPA and deviation management
• Non‑Conformance Report (NCR) processing
• Document control and SOP management
• Supplier quality management
• Post‑market surveillance
• Data analysis and reporting
• Quality Management System (QMS) tools