Sr. Microbiology Quality Engineer

Job Overview Sr Microbiology Quality Engineer – Responsible for Leading and managing Complaint Defect Tracking & Resolution (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. Authors and reviews technically sound investigation summaries and customer‑facing reports and interfaces directly with customers through written and verbal communication. Requires close collaboration with cross‑functional teams to ensure timely, compliant, and effective resolution of post‑market quality issues. 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 record. Ability to lift, move or carry equipment up to 50 lb, and 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. 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 View phone number on click.appcast.io or View email address on click.appcast.io. #J-18808-Ljbffr Cytiva