Quality Engineer I

Posted Yesterday
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Humacao, PRI
In-Office
Mid level
Pharmaceutical
The Role
Develops and maintains quality standards for medical device manufacturing. Collaborates with engineering and manufacturing teams, designs inspection and testing methods, conducts quality assurance testing, performs statistical analysis, investigates nonconformances, supports validation and risk assessments, and ensures corrective actions and documentation meet reliability and compliance requirements.
Summary Generated by Built In

For engineering services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering, and three (3) years of exposure within the Medical Devices Industry.
  • Bilingual: Spanish and English
  • Soft Skills: Excellent teamwork skills
  • Shift: 1st & 2nd Shift and according to business needs. 
  • Experience in: 
    • Manufacturing process and quality activities
    • Investigations, validation deliverables, risk assessments, and product/process performance monitoring.

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.
  • Performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant 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 Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?

Skills Required

  • Bachelor’s degree in Mechanical, Biomedical, Industrial, or Chemical Engineering
  • Three years of exposure within the medical devices industry
  • Bilingual Spanish and English proficiency
  • Excellent teamwork skills
  • Experience with manufacturing processes and quality activities
  • Experience with investigations, validation deliverables, risk assessments, and product or process performance monitoring
  • Availability for first or second shift according to business needs
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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