Sr. Microbiology Quality Engineer

• ◆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.

• ✓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

• ✓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

• ✓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 .

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.

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 .