Sr. Microbiology Quality Engineer

Radiometer; Hauppauge (NY); On-site; USD 112,000 - 125,000; Full time

Benefits offered by this job

Bonus/incentive pay

Medical/dental/vision insurance

401(k)

Job summary

Cytiva in Hauppauge, NY is seeking a Sr Microbiology Quality Engineer to lead post‑market quality activities, including CDT/ER investigations, containment, CAPA planning, and field actions. The role focuses on customer-facing reports, regulatory compliance, and cross‑functional teamwork to drive improvements.

Applicants should have a microbiology background, 5+ years in GMP environments, and proficiency with Excel, statistics (Minitab), and ISO13485/cGMP systems. On‑site role with benefits.

Qualifications

• Bachelor’s degree, microbiology preferred; ASQ or related certs encouraged.
• Minimum 5 years in a regulated GMP environment (medical devices or pharma).
• At least 3 years coordinating post-market surveillance, including complaints, investigations and CAPA management.

Responsibilities

• Lead CDT/ER activities: triage, trend analysis and investigations for post‑market quality issues.
• Author/review investigation summaries and customer-facing reports; interface with customers as needed.
• Provide SME on containment, root cause analysis, investigation execution and CAPA planning for internal nonconformances.
• Manage field actions and conduct formal risk assessments; ensure escalation and regulatory compliance.
• Generate/interpret quality metrics for nonconformances, CAPAs, complaints and field actions; drive continuous improvement.

Skills

Microbiology

Quality engineering

GMP

ISO 13485

Statistical analysis

MicrosoftExcel

PowerPoint

Education

Bachelor's degree in microbiology

ASQ certification / professional society training

Tools

Minitab

Quality Management System (QMS)

MS Office

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life‑saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life‑changing career. Learn about the Danaher Business System which makes everything possible. The Sr Microbiology Quality Engineer is responsible for Leading and managing Complaint Defect Tracking & Resolution (CDT&ER) activities for assigned products—including complaint trend analysis, tracking of significant quality issues and corrective actions, triage of incoming complaints, and support and coordination of investigations. This role also authors and reviews technically sound investigation summaries and customer‑facing reports and interfaces directly with customers through written and verbal communication. The position requires close collaboration with cross‑functional teams to ensure timely, compliant, and effective resolution of post‑market quality issue This position reports to the Quality Manager and is part of the Quality Department, located in Hauppauge,NY and will be an on‑site role.

What you will do:

• Lead CDT&ER 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.

Who you are:

• 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 is required, along with 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 50lb, any other physical requirements.
• It would be a plus if you also possess previous experience in: Advanced statistical analysis tools, like Minitab or quality engineering certifications Working knowledge of USP 61 & 62.

The salary range for this role is 112,000-125,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or [e-mail].

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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