Quality Engineer

FITS LLC; Añasco (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

FITS LLC, a service provider in the island and the US, seeks a Quality Engineering professional to support new products and processes in the Pharmaceutical and Medical Devices sectors.

The role focuses on validating and certifying processes, test methods, equipment, and utilities, while ensuring GMP and GDP compliance and robust quality documentation. You will collaborate across functions to maintain product quality and regulatory alignment.

Qualifications

• Bachelor's degree in Engineering with 3+ years in Quality within pharma/medical devices.
• Bilingual in Spanish and English with good communication.
• Shift: Administrative role per business needs.
• Experience in Validation Life Cycle, Change Control, Documentation, GMP & GDP regulations.

Responsibilities

• Support the implementation of effective quality engineering processes for new products, processes, and technology.
• Provides support to the validation and certification of process, test methods, equipment, software, utilities, and facilities as required.
• Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.
• Provides support on activities, documents and records requiring Quality Engineering review and/or approval as deemed necessary.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
• Works with multi-functional teams to establish project plans and ensure uninterrupted support to new projects balanced with manufacturing operations.
• Develops standard operating procedures, specifications, and provides technical transfer and validation support.
• Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.

Skills

Bilingual Spanish English

Education

Bachelor's Degree in Engineering

Job description

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree inEngineering and at least three(3) years of previous exposure to Quality activities within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in:
  • Validation Life Cycle
  • Change Control
  • Documentation
  • GMP & GDP regulations

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 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 take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Support the implementation of effective quality engineering processes for new products, processes, and technology.
• Provides support to the validation and certification of process, test methods, equipment, software, utilities, and facilities as required.
• Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.
• Provides support on activities, documents and records requiring Quality Engineering review and/or approval as deemed necessary.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
• Works with multi-functional teams to establish project plans and ensure uninterrupted support to new projects balanced with manufacturing operations.
• Develops standard operating procedures, specifications, and provides technical transfer and validation support.
• Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.

WHO WE ARE:

We are a Service Provider companydifferent 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 industryclients with top-notch quality talent.We're FITS!

Are you the next piece?