Quality Assurance Specialist II (Quality Engineering)

Location: On-site in Fajardo, Puerto Rico

Company

hirify.global’s Cytiva operating company develops solutions for biological research, vaccines, medicines, and cell and gene therapies.

What you will do

• Provide daily Quality Operations support for Filtration and D&M manufacturing areas, including floor support, documentation review, issue triage, and escalation of compliance or product-quality risks.
• Support customer complaint handling by reviewing information, coordinating sample receipt and analysis, documenting investigations, and preparing evidence-based response inputs.
• Lead or support investigations and nonconformance assessments, including root cause analysis, risk evaluation, containment, disposition, and closure.
• Partner with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams to resolve issues and maintain compliant operations.
• Use quality-system data, complaint trends, nonconformances, and process-gap analysis to support continuous improvement and prevent recurrence.

Requirements

• Bachelor’s degree in Biology, Microbiology, Engineering, or a related scientific or technical discipline.
• 5–10 years of experience in regulated life sciences, medical device, pharmaceutical, biotechnology, or manufacturing environments.
• Experience supporting cleanroom or controlled-environment operations, including environmental and contamination controls.
• Experience with quality investigations, customer complaints, nonconformances, root cause analysis, CAPA, risk assessments, or change control within a Quality Management System.
• Proficiency with electronic quality systems and digital tools, including AI-enabled tools, data analysis, or automation for investigations, metrics, prioritization, or continuous improvement.
• Ability to travel approximately 2%; valid driver’s license with an acceptable driving record; ability to lift, move, or carry equipment up to 10 lb.

Nice to have

• Experience with DBS, Lean Six Sigma, or the Toyota Lean System.
• Experience with cleanroom management and controlled environments.
• Experience in life sciences, pharmaceuticals, or medical devices.

Culture & Benefits

• Work within hirify.global’s continuous-improvement system and quality-focused operating environment.
• Collaborate with cross-functional teams supporting products that contribute to research, medicines, vaccines, and advanced therapies.
• Join a culture focused on belonging, innovation, customer impact, and compliant operations.