Quality Engineer II

Danaher•Fajardo, PR

1d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Generation, review, and interpretation of quality data, metrics, and reports to support decision making.
Experience working in compliance with ISO 13485 or GMP regulations.

Responsibilities

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.