Quality Engineer II - 100

Reposted 8 Days Ago
Be an Early Applicant
Juncos
In-Office
Mid level
Pharmaceutical
The Role
Responsible for maintaining quality standards in manufacturing, collaborating with teams, conducting statistical analyses, and ensuring compliance in documentation and processes.
Summary Generated by Built In

For Industrial services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering (Preferred Mechanical, Electrical, or Chemical) and Three (3) 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), and Critical Thinking.
    • Process, Computer validations (not cleaning processes), and Equipment document: URS, FAT, IQ, OQ, PQ. 
    • Minitab (statistical analysis). 

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.
  • Develop and implement 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. 
  • Investigating manufacturing operations events in support of product disposition.
  • Assessing and tracing manufacturing defects/rejects trends.
  • Designing validation strategies (e.g, requirements flow down from design to manufacturing).
  • Statistical techniques to analyze data capable of developing, reviewing, and approving test plans and reports. 

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

Capa
Computer Validations
Investigations
Minitab
Pfmea
Process Validations
Risk Management
Root Cause Analyses
Technical Writing
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

In-Office
Manatí, PRI
40384 Employees
15-15 Hourly

ABB Logo ABB

Intern

Robotics • Analytics • Energy
In-Office
Vega Baja, PRI
104000 Employees
In-Office
Manatí, PRI
40384 Employees
15-15 Hourly
In-Office
Manatí, PRI
40384 Employees
69K-84K Annually

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
Pharmaceutical • Logistics • Healthtech
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