Associate Quality Engineer

Posted 10 Days Ago
Be an Early Applicant
Caguas
In-Office
Mid level
Pharmaceutical
The Role
The Associate Quality Engineer develops product quality plans, documents, and systems, implements change management, writes protocols, and acts as a liaison with cross-functional areas to resolve quality issues.
Summary Generated by Built In

For engineering services in the quality area. 
WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering with experience in the Pharmaceutical or Medical Device industry.
  • Bilingual (English & Spanish). 
  • Project Management skills. 
  • Shift: Administrative and according to business needs. 
  • Experience in:
    • Quality and/or Compliance. Product quality plans, documents, and quality systems.
    • Application and principles of Manufacturing/Process
      Engineering.
    • Effectively communicate cross-functionally to assist with resolving
      Quality/Engineering issues.
    • Office applications: Word, PowerPoint, Excel.

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)

  • Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses.
  • Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.
  • Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
  • Can generate and approve qualification and validation protocols and reports with minimal oversight.
  • Monitor progress and performance against the project plan.
  • Anticipates potential situations that may impact projects timeline and resolves them before they become an issue.
  • Can generate and approve qualification and validation protocols and reports with minimal oversight.
  • Is the technical liaison with other cross functional areas with other sites.

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?

Top Skills

Excel
Office Applications: Word
PowerPoint
Am I A Good Fit?
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The Company
HQ: Guaynabo, PR
76 Employees
Year Founded: 2008

What We Do

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 We The Right Piece For You?
We are:

Experienced and knowledgeable in the Industry
Committed to Safety
Always compliant with FDA Regulations & Audits
Cost Effective
Proven successful track record
Over ten (10) years of experience

If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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