Quality System Analyst

hace 2 semanas


Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

For Quality services in the Manufacturing area.
WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Science or Engineering and at least five (5) years of previous exposure to Quality activities within the regulated industry.
Bilingual: (Spanish and English) Shift: Administrative & according to business needs  Experience in: Quality system requirements including familiarity with US FDA 21 CFR Part 820 and ISO 13485 regulations.  Use of applications/systems that support our quality system such as document management system, change control, non-conformance, CAPA, audit, metrics reporting systems, etc.
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 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 take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Monitors and tracks all sources of quality detractors utilizing various sources as systems and records.
Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations.
Develops solutions to database problems of moderate scope and complexity.
Writes and assists others in writing standard operating procedures.
Generates and identifies significant trends.
Regularly reports them to management and appropriate cross functional teams.
Provides advanced technical assistance in the use of information mapping technology.
Provides support to product review and release functions.
Generates moderately complex statistical summaries.
Uses quality tools and computer generated reports to continuously improve process capabilities.
Provides support to good manufacturing practice auditing and site readiness activities.
Provides supports collecting inputs for the management review and data review boards.
Verifies that quality systems are effectively deployed.
Performs periodic routine checks to verify appropriate application.
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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