Sr. Microbiology Quality Engineer

About the role

At Cytiva, one of Danaher’s 15+ operating companies, you’ll lead and manage Complaint Defect Tracking & Resolution (CDT&R) activities for assigned products. This includes complaint trend analysis, tracking of significant quality issues and corrective actions, triage of incoming complaints, and support and coordination of investigations. You’ll author and review technically sound investigation summaries and customer-facing reports, interface directly with customers, and collaborate with cross-functional teams to ensure timely, compliant, and effective resolution of post-market quality issues. This on-site role reports to the Quality Manager and is based in Hauppauge, NY.

Responsibilities

• 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, and 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.

Requirements

• Bachelor’s degree, with a preference for candidates with a microbiology background and/or advanced education or professional training through ASQ or a relevant professional society, or a master’s degree program.
• Minimum of five years of relevant industry experience in a regulated environment such as GMP medical devices or pharmaceuticals.
• At least three years of hands-on experience coordinating post-market surveillance and quality assurance activities, including complaint triage, investigations, and CAPA management; four to six years of such experience is preferred.
• Demonstrated microbiology laboratory competence, including microscopic differentiation of microorganisms (bacteria, yeast, mold), Gram staining, and environmental monitoring in controlled manufacturing environments.
• Proficiency with Microsoft Excel (formulas, pivot tables), PowerPoint, Word, and Teams, and experience analyzing data using statistical tools.
• Experience with cGMP and/or ISO 13485 quality systems, including documentation practices, audits, post-market surveillance, change control, and validation.

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel – up to 10%.
• Must have a valid driver’s license with an acceptable driving record.
• Ability to lift, move, or carry equipment up to 50 lb, along with any other physical requirements.

Preferred Qualifications

• Advanced statistical analysis tools, like Minitab or quality engineering certifications.
• Working knowledge of USP 61 & 62.

Pay

The salary range for this role is $112,000–$125,000. This range may be modified in the future. The role is also eligible for bonus/incentive pay.

Benefits

Cytiva offers a comprehensive package of benefits, including:

• Paid time off.
• Medical, dental, and vision insurance.
• 401(k) retirement plan.