Sr. Microbiology Quality Engineer

Location: On-site in Hauppauge, New York, United States

Salary: $112,000–$125,000 per year, plus bonus/incentive eligibility.

Company

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

What you will do

• Lead complaint defect tracking and resolution activities, including complaint triage, trend analysis, and investigation coordination.
• Author and review investigation summaries and customer-facing technical reports, communicating with customers in writing and verbally.
• Provide expertise in containment actions, root cause analysis, investigations, and CAPA planning.
• Manage field actions and formal risk assessments, including escalation, documentation, and regulatory compliance.
• Generate and present quality metrics for nonconformances, CAPAs, complaints, and field actions.
• Apply microbiological laboratory competence and contribute to continuous improvement initiatives.

Requirements

• Bachelor’s degree; microbiology background, advanced education, or relevant professional training is preferred.
• At least five years of relevant industry experience in a regulated GMP medical device or pharmaceutical environment.
• At least three years of hands-on experience with post-market surveillance, quality assurance, complaint triage, investigations, and CAPA management.
• Microbiology laboratory competence, including microscopic differentiation of bacteria, yeast, and mold, Gram staining, and environmental monitoring in controlled manufacturing environments.
• Proficiency with Microsoft Excel, PowerPoint, Word, Teams, and statistical data analysis tools.
• Experience with cGMP and/or ISO 13485 quality systems, documentation, audits, post-market surveillance, change control, and validation.

Nice to have

• Advanced statistical analysis tools such as Minitab or quality engineering certifications.
• Working knowledge of USP 61 and 62.

Culture & Benefits

• Paid time off.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) for eligible employees.
• Up to 10% travel.
• Valid driver’s license and acceptable driving record required; the role may involve lifting, moving, or carrying equipment up to 50 lb.