Quality Operations Manager Jobs in Puerto Rico (NOW HIRING)

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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

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