Quality Engineer
For quality services in the engineering area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s Degree in Engineering field and minimum of two (2) years of experience Quality and/or Compliance in the Medical Device or Pharmaceutical industry regulated industries.
- Bilingual (Spanish and English).
- Excellent communication skills
- Shift: Administrative & according to business needs.
- Experience in:
- Capital Projects
- Cost Improvement Projects
- IQ/OQ/PQ validations or Product Transfers is preferred but not required.
- Quality Systems, Risk Assessments, and FMEAs.
- Change Management and impact assessments.
- Qualification and validation protocols/reports.
- Monitoring project progress and deliverables.
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)
Key Responsibilities include, but are not limited to, the following:
- Serve as the primary Quality Assurance (QA) support for day-to-day manufacturing operations.
- Collaborate with Line Supervisors, Investigation Quality Engineers, and Manufacturing Engineers to address manufacturing line opportunities.
- Serve as the QA Management Representative on the manufacturing line and work directly with the production workforce.
- Oversee procedural readiness, execution, remediation, and effectiveness.
- Track and report Quality Improvement actions and projects.
- Provide monthly reporting on quality improvement activities.
- Lead Quality Improvement Projects, including initiating Change Requests / Change Orders as necessary.
- Ensure implemented changes are effective and sustainable.
- Provide support to Investigation Engineers as needed.
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?
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