Quality Assurance Specialist II
On-siteFajardo, Fajardo, Puerto Rico
Job Summary
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. This on-site role at the Fajardo site reports to the Sr. Manager QA Engineering and requires a valid driver's license with 2% travel.
Required Qualifications
- Bachelor's degree in Biology, Microbiology, Engineering, or a related scientific or technical discipline
- 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
- Ability to travel 2% (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
Desired Qualifications
- DBS, Lean Six Sigma, Toyota Lean System
- Cleanroom Management and Controlled Environments
- Life Sciences, Pharmaceuticals and Medical Devices
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