Quality Engineer

Caguas, PR, Puerto Rico
Contracted
SH Structural Heart (SH)
Entry Level

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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