Quality Assurance Specialist II

Cytiva; Puerto Rico; On-site; USD 85,000 - 110,000; Full time

Job summary

Cytiva in Fajardo, Puerto Rico, is seeking a Quality Engineering Specialist to provide primary Quality Operations support to Filtration and D&M units, ensuring compliant and timely manufacturing activities, documentation, data review, and issue resolution.

You will collaborate with cross-functional teams to drive investigations, CAPA, and continuous improvement using DBS, maintaining a compliant operation in a fast-paced environment.

Qualifications

• Bachelor’s degree in Biology, Microbiology, Engineering, or related field.
• Minimum 5–10 years in regulated life sciences, medical device, pharmaceutical, biotechnology, or manufacturing environments.
• Experience supporting cleanroom or controlled environment operations and quality oversight.
• Experience leading investigations, customer complaints, nonconformances, ROOT cause analysis, CAPA, risk assessments, or change control within a QMS.

Responsibilities

• Provide day-to-day Quality Operations support for Filtration and D&M manufacturing areas, including floor support and documentation review.
• Review complaints, coordinate sample receipt/analysis, document investigations, and prepare inputs for interim/final responses.
• Lead or support investigations and nonconformance assessments with containment, disposition, and timely closure.
• Collaborate with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams for cross-functional issue resolution.
• Identify and execute continuous improvement using DBS and quality system data to improve quality and prevent recurrence.

Skills

Quality investigations

CAPA & change control

Data analysis

Cross-functional collaboration

AI-assisted analysis

Education

Bachelor's degree in Biology/Engineering

Tools

Electronic quality systems

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

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.

Quality Engineering Specialist

The Quality Engineering Specialist is responsible for providing primary Quality Operations support to Filtration and D&M units at the Fajardo site, ensuring compliant and timely manufacturing activities, documentation, data review, and issue resolution. Also supports cross functional execution, serves as RTC backup, and assists with complaint handling and minor investigations to maintain continuity and compliance.

This position reports to the Sr. Manager QA Engineering 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

• Provide day-to-day Quality Operations support for Filtration and D&M manufacturing areas, including manufacturing floor support, documentation review, quality issue triage, and timely escalation of compliance or product quality risks.
• Support customer complaint handling by reviewing complaint information, coordinating sample receipt and analysis, documenting investigation activities, and preparing clear, evidence-based inputs for interim and final customer responses.
• Lead or support investigations and nonconformance assessments, including problem statement development, impact and risk evaluation, root cause analysis, containment, disposition, and timely closure in accordance with applicable procedures.
• Partner with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams to drive cross-functional issue resolution, ensure accurate record documentation, and maintain continuity of compliant operations.
• Identify, support, and execute continuous improvement opportunities using DBS and quality system data, including complaint trends, recurring nonconformances, process gaps, and investigation outcomes to improve quality performance and prevent recurrence.

Who You Are

• Bachelor’s degree in Biology, Microbiology, Engineering, or a related scientific or technical discipline.
• Long-standing experience (Minimum of 5-10 years in regulated life sciences, medical device, pharmaceutical, biotechnology, or manufacturing environments.
• Demonstrated experience supporting cleanroom or controlled environment operations, including environmental controls, contamination control practices, or cleanroom-related quality oversight.
• Demonstrated experience leading or supporting quality investigations, customer complaints, nonconformances, root cause analysis, CAPA, risk assessments, or change control within a Quality Management System.
• Proficiency using electronic quality systems and digital tools, with experience applying AI-enabled tools, data analysis, or automation to support investigation quality, prioritization, metrics, or continuous improvement activities.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

if applicable for role

• Ability to travel – list specifics 2% travel, overnight, within territory or locations
• Must have a valid driver’s license with an acceptable driving record
• Ability to lift, move or carry equipment up to 10lb, any other physical requirements

It would be a plus if you also possess previous experience in:

• DBS, Lean Six Sigma, Toyota Lean System
• Cleanroom Management and Controlled Environments
• Life Sciences, Pharmaceuticals and Medical Devices

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 [e-mail].