Sr. Quality Engineer - 102

Reposted 5 Days Ago
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Juncos
In-Office
Senior level
Pharmaceutical
The Role
Develops and maintains quality standards in manufacturing, collaborates with teams to ensure compliance, and conducts inspections and evaluations.
Summary Generated by Built In

For Validation services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering (Preferred Mechanical, Electrical, or Chemical) and five (5) years of experience within the Medical Devices Industry.
  • Bilingual: Spanish and English
  • Soft Skills: Writing and communication skills
  • Shift: 1st, 2nd, and according to business needs. 
  • Experience in: 
    • CAPA, Investigations, Root Cause Analyses, and Technical Writing.
    • Risk Management (pfmea), Change Control, and Computer Software. 
    • Process, Computer validations (not cleaning processes), and Equipment document: URS, FAT, IQ, OQ, PQ. 
    • Projects (Design requirements validation, manufacturing controls). 

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)

  • Develops, modifies, applies, and maintains quality standards.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Develops and implements methods and procedures for inspecting, testing, and evaluating products and production equipment.
  • Performs statistical analysis.
  • Ensures that documentation is compliant with requirements.
  • May specialize in the areas of design, production control, product evaluation, and reliability as they apply to product or process quality.

WHO WE ARE:

We are a service provider company that is different from the rest. We pride ourselves on 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 Devic,e and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?

Top Skills

Capa
Computer Software
Equipment Validation
Process Validation
Risk Management
Technical Writing
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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