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Quality Engineer

Flexible & Integrated Technical Services, LLC · fitspr.com
CaguasContract
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The job in short

A contract Quality Engineer role at Flexible & Integrated Technical Services, LLC in Caguas. Skills mentioned: Compliance.

Compliance

Details

Found
6 d ago · posted 2026-11-04
Location
Caguas, PR

Full description

For quality services in the engineering area. WHAT MAKES YOU A FIT: The Technical Part: • Bachelor’s Degree in Engineering field and minimum of two (2) years of experience Quality and/or Compliance in the Medical Device or Pharmaceutical industry regulated industries. • Bilingual (Spanish and English). • Excellent communication skills • Shift: Administrative & according to business needs. • Experience in: • Capital Projects • Cost Improvement Projects • IQ/OQ/PQ validations or Product Transfers is preferred but not required. • Quality Systems, Risk Assessments, and FMEAs. • Change Management and impact assessments. • Qualification and validation protocols/reports. • Monitoring project progress and deliverables. The Personality Part: • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Key Responsibilities include, but are not limited to, the following: • Serve as the primary Quality Assurance (QA) support for day-to-day manufacturing operations. • Collaborate with Line Supervisors, Investigation Quality Engineers, and Manufacturing Engineers to address manufacturing line opportunities. • Serve as the QA Management Representative on the manufacturing line and work directly with the production workforce. • Oversee procedural readiness, execution, remediation, and effectiveness. • Track and report Quality Improvement actions and projects. • Provide monthly reporting on quality improvement activities. • Lead Quality Improvement Projects, including initiating Change Requests / Change Orders as necessary. • Ensure implemented changes are effective and sustainable. • Provide support to Investigation Engineers as needed. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

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