Quality Assurance Specialist II

Danaher•Barrio Pueblo, PR

1d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.