Sr. Quality Specialist/Engineer

Posted 19 Days Ago
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Juncos, PRI
In-Office
Senior level
Pharmaceutical
The Role
This role involves supporting quality assurance in manufacturing, including compliance, systems validation, and IT systems integration, requiring communication and teamwork.
Summary Generated by Built In

For Quality services in the Manufacturing/Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor's Degree in Engineering or Life Sciences and at least five (5) years of experience in Quality activities within the medical device industry.
  • Bilingual (English & Spanish).
  • Shift: Administrative and according to business needs
  • Experience in:
    • Quality Systems & Compliance
    • Problem solving
    • Computer Systems Validation
    • It Systems and integrations with manufacturing equipment

The Personality Part:    

  • 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! 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. Bring it on!

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

  • Support quality assurance and compliance activities within a manufacturing environment.
  • Provide support for IT systems and integrations with manufacturing equipment.
  • Execute and support Computer Systems Validation (CSV) activities.
  • Ensure compliance with quality systems, procedures, and applicable regulations.
  • Collaborate with cross-functional teams to support manufacturing operations and continuous improvement initiatives.

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?

Skills Required

  • Bachelor's Degree in Engineering or Life Sciences
  • Five years of experience in Quality activities within the medical device industry
  • Bilingual in English & Spanish
  • Experience in Quality Systems & Compliance
  • Problem solving skills
  • Experience with Computer Systems Validation
  • Knowledge of IT Systems integrations with manufacturing equipment
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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