Quality Engineer II - 083

Reposted 16 Days Ago
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Juncos
In-Office
Mid level
Pharmaceutical
The Role
The Quality Engineer II develops and maintains quality standards, conducts quality assurance tests, and collaborates with teams to ensure product precision.
Summary Generated by Built In

For engineering services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering (preferred as Mechanical, Chemical, Industrial),  and four (4) years of experience within the Medical Devices Industry.
  • Bilingual: Spanish and English
  • Soft Skills: Excellent teamwork skills
  • Shift: 1st and according to business needs. 
  • Experience in: 
    • Reviewing and approving Validation test plans, reports, and deviations.  
    • Perform statistical analysis (Minitab) to support validations and product release. 
    • Risk Management documentation: pFMEAs, Equipment documentation: URS, FAT, IQ, OQ, PQ, TMV.
    • Defining validation strategies. 

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 and protocol for processing materials into partially finished or finished materials products.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment.
  • Conducts quality assurance tests and performs statistical analysis to assess the cost and determine the responsibility for products or materials.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation complies with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research.

WHO WE ARE:

We are a Service Provider company 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

Minitab
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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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