Flexible & Integrated Technical Services, LLC

Associate Quality Engineer

Medical Device - Caguas, PR, Puerto Rico - Contracted

For Quality services in the Engineering area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree and or an equivalent of two (2) years of experience in regulated industries. 
  • Bilingual (Spanish and English). 
  • Good organizational and problem-solving skills. 
  • Shift: Administrative & according to business needs. 
  • Experience in:
    • Non-conformance. 
    • Technical Writing. 
    • Validation Knowledge. 
    • Documentation, Compliance and applicable regulations. 
    • Effectively communicate cross-functionally to assist with resolving Quality issues.

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)

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming material.
  • Leads identification of primary root causes for basic investigations, identifies appropriate corrective and preventive actions.
  • Supports line support team (QC Supervisor, Mfg Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance.
  • Owns basic to moderate exception / CAPA activities without oversight.
  • May be responsible for working with process owner to bound product stops and document release criteria.
  • Can perform lot to lot yield and rework evaluation.
  • May be responsible for reporting of quality metrics.
  • Understands product quality plans, documents, and quality systems.
  • Develops product quality plans, documents and systems by providing input to product specifications, quality specifications.
  • Quality plans, risk analyses, FMEAs in conjunction with other product development team members.
  • May be responsible for owning and maintaining product risk analyses and FMEAs.
  • Monitors process by using process monitoring tools and Infinity QS to reduce process variation

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?

Apply: Associate Quality Engineer
* Required fields
First name*
Last name*
Email address*
Location
Phone number*
Resume*

Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or paste resume

Paste your resume here or attach resume file

What’s your citizenship / employment eligibility?*
Human Check*