Quality Assurance Specialist II

About the role

The Quality Assurance Specialist II provides primary Quality Operations support to the Filtration and D&M manufacturing units at Cytiva’s Fajardo site. You will ensure compliant, timely manufacturing activities, manage documentation, review data, and resolve quality issues.

Key responsibilities

• Provide day‑to‑day Quality Operations support on the manufacturing floor, including documentation review and quality issue triage.
• Support customer complaint handling: review complaints, coordinate sample receipt and analysis, document investigations, and prepare evidence‑based responses.
• Lead or support investigations and non‑conformance assessments, covering root‑cause analysis, containment, disposition, and timely closure.
• Partner with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams to drive cross‑functional issue resolution and maintain compliant operations.
• Identify and execute continuous‑improvement opportunities using Danaher Business System data, complaint trends, and recurring non‑conformances.

Required profile

• Bachelor’s degree in Biology, Microbiology, Engineering, or a related scientific/technical discipline.

Required skills

• Root Cause Analysis
• Complaint Handling
• Quality Investigation Management

What we offer

• Opportunity to work at the forefront of life‑sciences, diagnostics, and biotechnology.
• Collaborative culture focused on continuous improvement and impact.