Quality Engineer II at Danaher in Fajardo, Fajardo, PR

Quality Engineer II Location: Fajardo, Puerto Rico 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 Quality Engineer is responsible for completing thorough customer complaint investigations, writing interim and final response letters for customers, and monitoring the entire customer complaint lifecycle. This position reports to the Sr. Quality Manager and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: Conduct thorough investigations of customer complaints to identify root causes and ensure effective resolution. Draft interim and final response letters to communicate findings and solutions to customers in a clear and timely manner. Monitor and oversee the entire customer complaint lifecycle, ensuring compliance with quality standards and timely closure. Collaborate with cross-functional teams to implement corrective and preventive actions based on investigation outcomes. Maintain accurate documentation and records related to complaint investigations and follow-up actions, supporting quality assurance processes. Who you are: Bachelor’s degree on science such as Biology, Microbiology or Engineering with professional experience in Quality, Life Sciences, Manufacturing or a related technical field. Progressive experience in a regulated manufacturing or laboratory environment (e.g. medical devices, pharmaceuticals or biopharma) Demonstrated working knowledge of Quality Management Systems (QMS), including at least three of the following: deviations/non-conformances, CAPA, complaints, investigations, change control, risk management, and document control. Demonstrated experience conducting root cause investigations using structured methodologies (e.g. 5-Why, Fishbone, FMEA), including the ability to analyze technical data, identify trends, and document clear, evidence-based conclusions suitable for audits and customer communication. Demonstrated ability to support audits and inspections, including preparation of objective evidence, responses to auditor questions, and participation in internal, customer, or regulatory audits within a regulated environment. Travel, Motor Vehicle Record & Physical/Environment Requirements:if applicable for role Ability to travel as needed to support workshop and Kaizen events Requirement to gown up, including donning appropriate cleanroom attire, to enter and work within cleanroom environments as necessary. It would be a plus if you also possess previous experience in: Generation, review, and interpretation of quality data, metrics, and reports to support decision making. Experience working in compliance with ISO 13485 or GMP regulations. 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. 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. 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 applyassistance@danaher.com.