Sr. Microbiology Quality Engineer

Sr Microbiology Quality EngineerAre 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.The Sr Microbiology Quality Engineer is responsible for leading and managing Complaint Defect Tracking & Resolution (CDT&R) 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 issues.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&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.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 recordAbility to lift, move or carry equipment up to 50lb, any other physical requirementsIt would be a plus if you also possess previous experience in:Advanced statistical analysis tools, like Minitab or quality engineering certificationsWorking knowledge of USP 61 & 62Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.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.Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. 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.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.