Sr Microbiology Quality Engineer

About the Role A Sr Microbiology Quality Engineer at Cytiva will lead and manage complaint defect tracking and resolution for assigned products, performing trend analysis and coordinating investigations to ensure timely and compliant post-market quality issue resolution. This role prepares investigation summaries and customer-facing reports and interacts directly with customers, while collaborating with cross-functional teams. The position reports to the Quality Manager, is part of the Quality Department, and is an onsite role in Hauppauge, NY. What You'll Do

• Lead CDT&R activities for assigned products, including complaint triage, trend analysis, and coordination of investigations to ensure timely and compliant resolution of post‑market quality issues.
• Author and review high‑quality investigation summaries and customer‑facing technical reports; interface directly with customers as needed.
• Provide subject matter expertise on containment actions, root cause analysis, investigation execution, and CAPA planning for internal nonconformances.
• Manage field actions and facilitate formal risk assessments, ensuring appropriate escalation, documentation, and regulatory compliance.
• Generate and present quality metrics related to nonconformances, CAPAs, complaints, and field actions; contribute to continuous improvement initiatives and apply microbiological laboratory competence. What We're Looking For
• Bachelor’s degree, preferably with a microbiology background; advanced education or professional training (ASQ or relevant society) or master’s degree; minimum five years in a regulated environment (GMP medical devices or pharmaceuticals) and at least three years coordinating post-market surveillance and QA activities; four to six years preferred.
• Demonstrated microbiology laboratory competence (e.g., microscopic differentiation of microorganisms, Gram staining, environmental monitoring in controlled manufacturing environments).
• Proficiency with Microsoft Excel (formulas, pivot tables), PowerPoint, Word, and Teams; experience analyzing data with statistical tools.
• Experience with cGMP and/or ISO 13485 quality systems, including documentation practices, audits, post‑market surveillance, change control, and validation.
• Travel up to 10%; valid driver’s license with acceptable driving record; ability to lift up to 50 lb; on-site role. Nice to Have
• Advanced statistical analysis tools (e.g., Minitab) or quality engineering certifications.
• Working knowledge of USP 61 & 62. Compensation & Benefits
• Salary range: 112,000–125,000 per year; bonus/incentive pay eligibility.
• Comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k).
• See Danaher benefits information for details.