jobapplier

Quality Engineer

Flexible & Integrated Technical Services, LLC

Skills

Required

  • validation
  • Medical Device
  • Microsoft Office
  • Excel
  • Word
  • Minitab
  • GMP

Preferred

  • IQ/OQ/PQ
  • Protocol Development and
  • Execution
  • Process Characterization
  • DOE Methodology
  • Validation TMV
  • statistical
  • test methods
  • manufacturing systems

About Flexible & Integrated Technical Services, LLC

  • Bring it on!
  • 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?

Responsibilities

  • IQ/OQ/PQ Protocol Development and Execution.
  • Process Characterization.
  • DOE Methodology.
  • Test Method Validation (TMV).
  • Inspection Method Validation (IMV).
  • Sprinkle on a love of the scientific method, teamwork, and, above all else, being ethical, and you just might have what it takes to take on this new challenge.
  • AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Responsible for executing validation protocols, assisting with statistical analysis, preparing technical documentation, and collaborating with cross-functional teams to ensure compliance with quality and regulatory requirements.
  • Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
  • Development and execution of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Characterization Studies, Test Method Validation (TMV), Inspection Method Validation (IMV), Design of Experiments (DOE).
  • Generate and review validation protocols, reports, and technical documentation.
  • Utilize Minitab for statistical analysis, process capability studies, data trending, and DOE analysis.
  • Support investigations, nonconformance evaluations, corrective actions, and process improvement initiatives.
  • Analyze manufacturing and quality data to identify trends and opportunities for improvement.
  • Collaborate with Engineering, Quality, Manufacturing, and Operations personnel to support project objectives.
  • Ensure all activities are completed in compliance with applicable quality system and regulatory requirements.

Requirements

  • Quality services in the Manufacturing/Engineering area.
  • The Technical Part: Bachelor's degree in Engineering and a minimum of two to three (2-3) years of experience in engineering, validation, quality, manufacturing, or a related technical field.
  • Experience within a regulated environment (Medical Device, Pharmaceutical, Biotechnology, or similar) preferred.
  • Bilingual (English & Spanish).
  • Administrative and according to business needs Experience in: Proficiency in Microsoft Office Suite: Excel, Word, Power Point, Microsoft Project.
  • Proficiency in Minitab for statistical analysis and data interpretation.
  • Knowledge of FDA, GMP, and ISO 13485 requirements.
  • Familiarity with risk management tools (FMEA, risk assessments).
  • If you have excellent communication skills and aren’t afraid to ask for help when you need it (in addition to your excellent Maintenance skills), this might be the job for you!