Associate Quality Engineer

Posted 12 Days Ago
Be an Early Applicant
Caguas
In-Office
Junior
Pharmaceutical
The Role
Responsible for compliance, identifying manufacturing defects, leading investigations, supporting quality activities, and developing quality plans and documentation.
Summary Generated by Built In

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?

Top Skills

Infinity Qs
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

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]

Similar Jobs

Optum Logo Optum

Call Center Representative ($750 Sign-On Bonus) - San Juan, PR

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office
San Juan, PRI
160000 Employees

Optum Logo Optum

Data Analyst

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office
San Juan, PRI
160000 Employees

Optum Logo Optum

Cybersecurity (Access Operations) - San Juan, PR

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office
San Juan, PRI
160000 Employees

Optum Logo Optum

Security Engineer

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office
San Juan, PRI
160000 Employees

Similar Companies Hiring

Formation Bio Thumbnail
Pharmaceutical • Healthtech • Biotech • Big Data • Artificial Intelligence
New York, NY
140 Employees
Pfizer Thumbnail
Pharmaceutical • Natural Language Processing • Machine Learning • Healthtech • Biotech • Artificial Intelligence
New York, NY
121990 Employees
Cencora Thumbnail
Healthtech • Logistics • Pharmaceutical
Conshohocken, PA
51000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account