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 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&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 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
Cytiva, 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. Check out our benefits at Danaher Benefits Info.
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.
For more information, visit www.danaher.com.
